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Medical Devices Ordinance
(MedDO)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 1 July 2020 (Status as of 26 May 2021)

The Swiss Federal Council,

based on the Therapeutic Products Act of 15 December 20001 (TPA),
Article 21 number 2 of the Electricity Act of 24 June 19022,
Article 5 of the Federal Act of 17 June 2011 on Metrology3,
Article 4 paragraph 1 of the Federal Act of 12 June 20094 on Product Safety,
Article 37 of the Radiological Protection Act of 22 March 19915 and
in implementation the Federal Act of 6 October 19956 on Technical Barriers to Trade,

ordains:

Chapter 1 General Provisions

Section 1 Scope and Exceptions

Art. 1 Scope  

1This Or­din­ance ap­plies to:

a.
med­ic­al devices and the as­so­ci­ated ac­cessor­ies, as defined in Art­icle 3;
b.
groups of products without an in­ten­ded med­ic­al pur­pose in ac­cord­ance with An­nex 1.

2 In this Or­din­ance, the term devices is used to des­ig­nate the products defined in para­graph 1.

3 This Or­din­ance also ap­plies to:

a.
devices which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part a medi­cin­al product that has an ac­tion an­cil­lary to that of the device;
b.
devices in­ten­ded to de­liv­er a medi­cin­al product;
c.
devices man­u­fac­tured:
1.
from tis­sue or cells of an­im­al ori­gin or their de­riv­at­ives which are non-vi­able or have been rendered non-vi­able,
2.
from de­riv­at­ives of tis­sue or cells of hu­man ori­gin that are non-vi­able or have been rendered non-vi­able;
d.
devices which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part non-vi­able tis­sue or non-vi­able cells of hu­man ori­gin or their de­riv­at­ives that have an ac­tion an­cil­lary to that of the device;
e.
devices that in­cor­por­ate as an in­teg­ral part an in vitro dia­gnost­ic med­ic­al device; such con­stitu­ent parts shall be sub­ject to the pro­vi­sions for in vitro med­ic­al devices.
Art. 2 Exceptions  

1 This Or­din­ance does not ap­ply to:

a.
hu­man blood, blood products, plasma or blood cells of hu­man ori­gin, or devices which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate such blood products, plasma or cells with the ex­cep­tion of the devices spe­cified in Art­icle 1 para­graph 3 let­ter a;
b.
vi­tal or­gans, tis­sues or cells and trans­plant products of hu­man ori­gin;
c.
vi­tal or­gans, tis­sues or cells and trans­plant products of an­im­al ori­gin;
d.
any items oth­er than those lis­ted in let­ters a–c that are com­posed of or con­tain vi­able bio­lo­gic­al sub­stances or vi­able or­gan­isms, in­clud­ing liv­ing mi­cro-or­gan­isms, bac­teria, fungi or vir­uses, in or­der to achieve or sup­port the in­ten­ded pur­pose of the device;
e.
in vitro dia­gnost­ic med­ic­al devices; these are sub­ject to Art­icles 105 and 107;
f.
non-sep­ar­able com­bin­a­tions of a medi­cin­al product and device in­ten­ded to de­liv­er a medi­cin­al product that are in­ten­ded solely for use in this com­bin­a­tion and are not re­usable;
g.
com­bin­a­tions which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part a medi­cin­al product in ad­di­tion to the device, where the medi­cin­al product as­sumes a primary func­tion in such com­bin­a­tions;
h.
com­bin­a­tions which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part non-vi­able tis­sue or non-vi­able cells of hu­man ori­gin or their de­riv­at­ives in ad­di­tion to the device, where such tis­sue, cells or de­riv­at­ives as­sume a primary func­tion in the device;
i.
med­ic­al devices in­ten­ded solely for use in an­im­als or veter­in­ary dia­gnostics.

2 In the cases spe­cified in para­graph 1 let­ters f–h, the part of the com­bin­a­tion that ful­fils the role of device must sat­is­fy the gen­er­al safety and per­form­ance re­quire­ments set out in Art­icle 6.

Section 2 Definitions and References to European Legislation

Art. 3 Medical device and accessories  

1 Med­ic­al devicesarein­stru­ments, ap­par­at­us, ap­pli­ances, soft­ware, im­plants, re­agents, ma­ter­i­als or oth­er ob­jects:

a.
that are in­ten­ded by their man­u­fac­turer for use in hu­man be­ings;
b.
that do not achieve their prin­cip­al in­ten­ded ac­tion in or on the hu­man body by phar­ma­co­lo­gic­al, im­mun­o­lo­gic­al or meta­bol­ic means, but which ac­tion can be as­sisted by such means; and
c.
that serve to ful­fil one or more of the fol­low­ing spe­cif­ic med­ic­al pur­poses either alone or in com­bin­a­tion:
1.
dia­gnos­is, pre­ven­tion, mon­it­or­ing, pre­dic­tion, pro­gnos­is, treat­ment or al­le­vi­ation of dis­ease,
2.
dia­gnos­is, mon­it­or­ing, treat­ment, al­le­vi­ation or com­pens­a­tion of in­jur­ies or han­di­caps,
3.
in­vest­ig­a­tion, re­place­ment or modi­fic­a­tion of the ana­tomy or of a physiolo­gic­al or patho­lo­gic­al pro­cess or con­di­tion,
4.
ac­quis­i­tion of in­form­a­tion by means of in vitro in­vest­ig­a­tion of samples ob­tained from the hu­man body, in­clud­ing donated or­gans, blood or tis­sue.

2Med­ic­al devices also in­clude:

a.
con­tra­cept­ive or fer­til­ity-en­han­cing products;
b.
items in­ten­ded spe­cific­ally to clean, dis­in­fect or ster­il­ise the devices lis­ted in Art­icle 1, para­graph 1 and in para­graph 1 of this Art­icle.

3 Med­ic­al device ac­cess­ory means any art­icle that is not a med­ic­al device in its own right, but which is in­ten­ded by its man­u­fac­turer to be used to­geth­er with one or more par­tic­u­lar med­ic­al devices and:

a.
which makes it pos­sible to use the med­ic­al device or devices in ac­cord­ance with its or their in­ten­ded pur­pose; or
b.
which spe­cific­ally and dir­ectly sup­ports the med­ic­al func­tion of the med­ic­al device or devices in line with its or their in­ten­ded pur­pose.
Art. 4 Further definitions  

1 In this Or­din­ance:

a.
mak­ing avail­able on the mar­ket means any sup­ply of a device, oth­er than an in­vest­ig­a­tion­al device, for dis­tri­bu­tion, con­sump­tion or use on the Swiss mar­ket in the course of a com­mer­cial activ­ity, wheth­er in re­turn for pay­ment or free of charge;
b.
pla­cing on the mar­ket means the first mak­ing avail­able of a device, oth­er than an in­vest­ig­a­tion­al device, on the Swiss mar­ket;
c.
put­ting in­to ser­vice means the stage at which a device, oth­er than an in­vest­ig­a­tion­al device, has been made avail­able to the fi­nal user as be­ing ready for use on the Swiss mar­ket for the first time for its in­ten­ded pur­pose;
d.
main­ten­ance means meas­ures such as mech­an­ic­al main­ten­ance, soft­ware up­dates, in­spec­tion, re­pair, pre­par­a­tion for first use and re­pro­cessing for re­use or meas­ures to keep a device in func­tion­al con­di­tion or re­store it to func­tion­al con­di­tion;
e.
re­pro­cessing means a pro­cess car­ried out on a used device in or­der to al­low its safe re­use in­clud­ing clean­ing, dis­in­fec­tion, ster­il­isa­tion and re­lated pro­ced­ures, par­tic­u­larly pack­ing, trans­port and stor­age, as well as test­ing and restor­ing the tech­nic­al and func­tion­al safety of the used device;
f.
man­u­fac­turer means a nat­ur­al or leg­al per­son who man­u­fac­tures or fully re­fur­bishes a device or has a device de­signed, man­u­fac­tured or fully re­fur­bished, and mar­kets that device un­der its name or trade­mark; this defin­i­tion is sub­ject to the cla­ri­fy­ing ex­plan­a­tions and ex­cep­tions in Art­icle 16 para­graphs 1 and 2 of Reg­u­la­tion (EU) 2017/7457 on med­ic­al devices (EU-MDR);
g.
au­thor­ised rep­res­ent­at­ive means any nat­ur­al or leg­al per­son dom­i­ciled in Switzer­land who has re­ceived and ac­cep­ted a writ­ten man­date from a man­u­fac­turer loc­ated in an­oth­er coun­try to act on the man­u­fac­turer's be­half in re­la­tion to spe­cified tasks with re­gard to the lat­ter's ob­lig­a­tions un­der this Or­din­ance;
h.
im­port­er means any nat­ur­al or leg­al per­son es­tab­lished with­in Switzer­land that places a device from a for­eign coun­try on the Swiss mar­ket;
i.
dis­trib­ut­or means any nat­ur­al or leg­al per­son in the sup­ply chain, oth­er than the man­u­fac­turer or the im­port­er, that makes a device avail­able on the Swiss mar­ket, up un­til the point of put­ting in­to ser­vice;
j.
eco­nom­ic op­er­at­or means the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er, dis­trib­ut­or or nat­ur­al or leg­al per­son as spe­cified in Art­icle 22 para­graphs 1 and 3 EU-MDR;
k.
health­care fa­cil­ity means any or­gan­isa­tion whose primary pur­pose is to provide care or treat­ment for pa­tients or to pro­mote pub­lic health;
l.
hos­pit­almeans any health­care in­sti­tu­tion in which in­pa­tient treat­ments for ill­nesses, in­pa­tient med­ic­al re­hab­il­it­a­tion and in­pa­tient med­ic­al meas­ures for cos­met­ic pur­poses are provided by med­ic­al or nurs­ing in­ter­ven­tions;
m.
con­tract­ing state means any state that is bound to mu­tu­ally re­cog­nise con­form­ity as­sess­ments and con­form­ity pro­ced­ures for devices by an agree­ment with Switzer­land un­der in­ter­na­tion­al law based on equi­val­ent le­gis­la­tion.

2 The defin­i­tions set out in Art­icle 2 num­bers 3–26, 31, 37, 38, 40–44, 46, 48, 51–53, 57–69 and 71 EU-MDR, tak­ing ac­count of the amend­ments to the defin­i­tions in Art­icle 2 num­bers 18–21 EU-MDR, ef­fected by the European Com­mis­sion by means of del­eg­ated acts8.

7 Reg­u­la­tion (EU) 2017/745 of the European Par­lia­ment and of the Coun­cil of 5 April 2017 on med­ic­al devices, amend­ing Dir­ect­ive 2001/83/EC, Reg­u­la­tion (EC) No 178/2002 and Reg­u­la­tion (EC) No 1223/2009 and re­peal­ing Coun­cil Dir­ect­ives 90/385/EEC and 93/42/EEC, OJ L117 of 5.5. 2017, p. 1; last amended by Reg­u­la­tion (EU) 202/561, OJ L 130 of 24.4.2020, p. 18.

8 See An­nex 4.

Art. 5 References to European legislation  

1 The equi­val­ent terms spe­cified in An­nex 2 and as used in EU-MDR9 and this Or­din­ance shall ap­ply.

2 Where this Or­din­ance makes ref­er­ence to pro­vi­sions of EU-MDR that in turn refer to oth­er pro­vi­sions of EU-MDR or oth­er EU acts of law, those pro­vi­sions shall also ap­ply. The in­ter­pret­a­tion in the foot­note to Art­icle 4 para­graph 1 let­ter f is au­thor­it­at­ive for ref­er­ences to EU-MDR, while the in­ter­pret­a­tions of the rel­ev­ant EU act set out in An­nex 3 num­ber 1 ap­ply to ref­er­ences to oth­er EU acts. This pro­vi­sion ex­cludes on­ward ref­er­ences to the EU acts lis­ted in An­nex 3 num­ber 2; here the Swiss terms lis­ted in the An­nex shall ap­ply.

9 See the foot­note to Art. 4 para. 1 let. f.

Chapter 2 Making available on the Market and Putting into Service

Section 1 Requirements

Art. 6 General safety and performance requirements  

1 A device may be placed on the mar­ket or put in­to ser­vice only if it com­plies with this Or­din­ance when duly sup­plied and prop­erly in­stalled, main­tained and used in ac­cord­ance with its in­ten­ded pur­pose.

2 Devices must con­form to the gen­er­al safety and per­form­ance re­quire­ments set out in An­nex I to EU-MDR10, tak­ing ac­count of their in­ten­ded pur­pose.

3 Ap­pro­pri­ate evid­ence that the part of the com­bin­a­tion that is deemed to be a device un­der the cases set out in Art­icle 2 let­ters f–h ful­fils the product re­quire­ments must be presen­ted to the com­pet­ent au­thor­ity on de­mand.

4 Com­pli­ance with the es­sen­tial re­quire­ments of this Or­din­ance, as covered by des­ig­nated tech­nic­al stand­ards11, com­mon spe­cific­a­tions or pre­scrip­tions of the phar­ma­co­poeia12, is pre­sumed if the device is in con­form­ity with these stand­ards, spe­cific­a­tions or pre­scrip­tions.

5 The pre­sump­tion made in para­graph 4 also ap­plies to com­pli­ance with the sys­tem or pro­cess re­quire­ments that eco­nom­ic op­er­at­ors must com­ply with un­der this Or­din­ance, in­clud­ing re­quire­ments as­so­ci­ated with qual­ity man­age­ment sys­tems, risk man­age­ment, post-mar­ket sur­veil­lance sys­tems, clin­ic­al tri­als, clin­ic­al eval­u­ation or post-mar­ket clin­ic­al fol­low-up.

6 Com­pli­ance with the com­mon spe­cific­a­tions in para­graph 4 is re­quired un­less the man­u­fac­turer can provide ap­pro­pri­ate proof that the solu­tions it has chosen guar­an­tee equi­val­ent con­form­ity with the safety and per­form­ance re­quire­ments. The above is sub­ject to Art­icle 8 para­graph 1.

10 See the foot­note to Art. 4 para. 1 let. f.

11 The elec­tric­al stand­ards can be ob­tained from the in­dustry as­so­ci­ation Elec­tro­suisse, Luppmen­strasse 1, 8320Fehraltorf, www.elec­tro­suisse.ch; the re­main­ing stand­ards can be ob­tained from the Swiss As­so­ci­ation for Stand­ard­iz­a­tion (SNV), Sulzer­allee 70, 8404Win­ter­thur, www.snv.ch.

12 SR 812.211

Art. 7 Distance sales  

1 Devices mar­keted by means of in­form­a­tion so­ci­ety ser­vices – spe­cific­ally an on­line ser­vice – that ful­fil the con­di­tions set out in para­graph 4 must com­ply with this Or­din­ance.

2 Sim­il­arly, devices that are not placed on the mar­ket but are used in the con­text of a com­mer­cial activ­ity, wheth­er in re­turn for pay­ment or free of charge, for the pro­vi­sion of a dia­gnost­ic or thera­peut­ic ser­vice offered by means of in­form­a­tion so­ci­ety ser­vices or by oth­er means of com­mu­nic­a­tion must also com­ply with this Or­din­ance.

3 Upon re­quest by the Swiss Agency for Thera­peut­ic Products (Swiss­med­ic), any nat­ur­al or leg­al per­son of­fer­ing a device in ac­cord­ance with para­graph 2 or provid­ing a ser­vice must be able make avail­able a copy of the de­clar­a­tion of con­form­ity.

4 A device is deemed to be sup­plied via an in­form­a­tion so­ci­ety ser­vice if that ser­vice:

a.
is provided by dis­tance selling, spe­cific­ally without the con­tract­ing parties be­ing phys­ic­ally present at the same time;
b.
is provided elec­tron­ic­ally; and
c.
is provided at the in­di­vidu­al re­quest of the re­cip­i­ent or the re­cip­i­ent’s rep­res­ent­at­ive.

5 To pro­tect pub­lic health, Swiss­med­ic may re­quire a pro­vider of in­form­a­tion so­ci­ety ser­vices to dis­con­tin­ue its activ­it­ies in Switzer­land.

Art. 8 Specific requirements  

1 Devices without an in­ten­ded med­ic­al pur­pose in ac­cord­ance with Art­icle 1 para­graph 1 let­ter b must com­ply with the com­mon spe­cific­a­tions stip­u­lated by Swiss­med­ic.

2 Devices that have both a med­ic­al and non-med­ic­al in­ten­ded pur­pose must ful­fil both the re­quire­ments for devices with a med­ic­al in­ten­ded pur­pose and the re­quire­ments for devices without an in­ten­ded med­ic­al pur­pose.

3 Devices that are also ma­chines with­in the mean­ing of Art­icle 1 of the Ma­chine Or­din­ance of 2 April 200813 must sat­is­fy the per­tin­ent gen­er­al safety and health pro­tec­tion re­quire­ments of the Ma­chine Or­din­ance where these re­quire­ments are more spe­cif­ic than those of Chapter II of An­nex I to EU-MDR14.

13 SR 819.14

14 See the foot­note to Art. 4 para. 1 let. f.

Art. 9 Devices manufactured and used in healthcare institutions  

1 Devices man­u­fac­tured and used solely with­in health­care in­sti­tu­tions are deemed to have been put in­to ser­vice. Such devices are sub­ject to the per­tin­ent gen­er­al safety and per­form­ance re­quire­ments of An­nex I to EU-MDR15 but not to any of the oth­er re­quire­ments set out in this Or­din­ance, provided the re­quire­ments of Art­icle 5 para­graph 5 let­ters a–h EU-MDR are ful­filled.

2 Para­graph 1 does not ap­ply to devices man­u­fac­tured on an in­dus­tri­al scale.

15 See the foot­note to Art. 4 para. 1 let. f.

Art. 10 Custom-made devices  

1 Cus­tom-made devices are sub­ject to the re­quire­ments of An­nex XIII to EU-MDR16. The de­clar­a­tion ac­cord­ing to Sec­tion 1 of An­nex XIII to EU-MDR must be en­closed when the devices are placed on the mar­ket.

2 In ad­di­tion to the pro­ced­ure un­der para­graph 1, man­u­fac­tur­ers of class III im­plant­able cus­tom-made devices must also con­duct a con­form­ity as­sess­ment pro­ced­ure as spe­cified in Chapter I of An­nex IX to EU-MDR. Al­tern­at­ively, they may opt for a con­form­ity as­sess­ment in ac­cord­ance with Part A of An­nex XI to EU-MDR.

3 Man­u­fac­tur­ers must cre­ate and up­date the doc­u­ment­a­tion spe­cified in Sec­tion 2 of An­nex XIII to EU-MDR and en­sure it can be made avail­able to the com­pet­ent au­thor­it­ies.

16 See the foot­note to Art. 4 para. 1 let. f.

Art. 11 Systems and procedure packs  

1 The re­quire­ments of Art­icles 22 and 29 para­graph 2 EU-MDR ap­ply to the pla­cing on the mar­ket of sys­tems and pro­ced­ure packs17.

2 Any nat­ur­al or leg­al per­son who ster­il­ises sys­tems or pro­ced­ure packs for pla­cing on the mar­ket must ap­ply a con­form­ity as­sess­ment pro­ced­ure for the ster­il­isa­tion pro­cess and in­volve in that pro­ced­ure a con­form­ity as­sess­ment body that is des­ig­nated un­der this Or­din­ance or re­cog­nised un­der an in­ter­na­tion­al agree­ment (des­ig­nated body). The mod­al­it­ies for do­ing so are gov­erned by Art­icle 22 para­graph 3 EU-MDR.

3 Any nat­ur­al or leg­al per­son who places the fol­low­ing sys­tems or pro­ced­ure packs on the mar­ket must ful­fil the ob­lig­a­tions of a man­u­fac­turer un­der Art­icles 46–50 and con­duct the per­tin­ent con­form­ity as­sess­ment pro­ced­ure un­der Art­icle 23: Sys­tems or pro­ced­ure packs that:

a.
con­tain devices that do not carry a con­form­ity mark­ing;
b.
con­sist of a com­bin­a­tion of devices that is not com­pat­ible with their ori­gin­al in­ten­ded pur­pose; or
c.
have not been ster­il­ised in ac­cord­ance with the man­u­fac­turer’s in­struc­tions.

17 See the foot­note to Art. 4 para. 1 let. f.

Art. 12 Parts and components  

1 Any nat­ur­al or leg­al per­son who makes avail­able on the mar­ket an item in­ten­ded to re­place an identic­al or sim­il­ar in­teg­ral part or com­pon­ent of a device that is de­fect­ive or worn in or­der to main­tain or re­store the func­tion of the device without chan­ging its per­form­ance or safety char­ac­ter­ist­ics or its in­ten­ded pur­pose shall en­sure that the item does not ad­versely af­fect the safety and per­form­ance of the device. Sup­port­ing evid­ence must be kept avail­able for the com­pet­ent au­thor­ity.

2 An item that is in­ten­ded spe­cific­ally to re­place a part or com­pon­ent of a device and that sig­ni­fic­antly changes the per­form­ance or safety char­ac­ter­ist­ics or the in­ten­ded pur­pose of the device shall be con­sidered to be a device and shall meet the re­quire­ments laid down in this Or­din­ance.

Art. 13 Conformity marking and identification number  

1 Devices placed on the mar­ket in Switzer­land or made avail­able on the Swiss mar­ket must bear a con­form­ity mark­ing in ac­cord­ance with An­nex 5. The con­form­ity mark­ing presen­ted in An­nex V to EU-MDR18 is also a per­miss­ible con­form­ity mark­ing.

2 The fol­low­ing must not bear a con­form­ity mark­ing:

a.
cus­tom-made devices;
b.
devices ex­clus­ively for demon­stra­tion and ex­hib­i­tion pur­poses;
c.
sys­tems and pro­ced­ure packs;
d.
in­vest­ig­a­tion­al devices, sub­ject to the pro­vi­sions of Art­icle 6 of the Or­din­ance of 1 Ju­ly 202019 on Clin­ic­al Tri­als with Med­ic­al Devices;
e.
devices man­u­fac­tured and used in health­care in­sti­tu­tions.

3 Where devices’ con­form­ity has to be as­sessed by a des­ig­nated body, the iden­ti­fic­a­tion num­ber of this body must be ap­pen­ded to the con­form­ity mark­ing.

18 See the foot­note to Art. 4 para. 1 let. f.

19 SR 812.213.3

Art. 14 Location of conformity marking and identification number  

1 The con­form­ity mark­ing and, where ne­ces­sary, as­so­ci­ated iden­ti­fic­a­tion num­ber must ap­pear on the device it­self or on its sterile pack­aging.

2 Where this is not pos­sible or prac­tic­able ow­ing to the com­pos­i­tion of the device, the con­form­ity mark­ing and, where ne­ces­sary, iden­ti­fic­a­tion num­ber must be dis­played on the pack­aging.

3 The con­form­ity mark­ing must also ap­pear on the in­struc­tions for use and trade pack­aging.

4 The re­quire­ments of Art­icle 20 para­graphs 3–6 EU-MDR20 and the gen­er­al prin­ciples of Reg­u­la­tion (EC) No. 765/200821 must also be ob­served when af­fix­ing the con­form­ity mark­ing.

20 See the foot­note to Art. 4 para. 1 let. f.

21 Reg­u­la­tion (EC) No. 765/2008 of the European Par­lia­ment and of the Coun­cil of 9 Ju­ly 2008 set­ting out the re­quire­ments for ac­cred­it­a­tion and mar­ket sur­veil­lance re­lat­ing to the mar­ket­ing of products and re­peal­ing Reg­u­la­tion (EEC) No 339/93, ver­sion ac­cord­ing to OJ L 218 of 13.8.2008, p. 30.

Section 2 Classification, Labelling and Device Identification

Art. 15 Classification  

1 Devices shall be di­vided in­to classes I, IIa, IIb and III, tak­ing in­to ac­count the in­ten­ded pur­pose of the devices and their in­her­ent risks. This clas­si­fic­a­tion must com­ply with the pro­vi­sions of An­nex VIII to EU-MDR22.

2 The pro­ced­ure for resolv­ing dis­putes between the man­u­fac­turer and a des­ig­nated body as re­gards the clas­si­fic­a­tion of a device is gov­erned by Art­icle 51 para­graph 2 EU-MDR.

22 See the foot­note to Art. 4 para. 1 let. f.

Art. 16 Product information  

1 Product in­form­a­tion com­prises the la­belling and in­struc­tions for use. It is gov­erned by Chapter III of An­nex I to EU-MDR23.

2 It must be writ­ten in all three of­fi­cial lan­guages of Switzer­land. Sym­bols es­tab­lished by means of tech­nic­al stand­ards may be used to re­place writ­ten state­ments.

3 The product in­form­a­tion may be provided in few­er than the three of­fi­cial lan­guages of Switzer­land or in Eng­lish, provided that:

a.
the device is sup­plied ex­clus­ively to pro­fes­sion­als or is a cus­tom-made device or a med­ic­al device man­u­fac­tured and used in a health­care in­sti­tu­tion;
b.
it is cer­tain that the user meets the ne­ces­sary pro­fes­sion­al and lin­guist­ic re­quire­ments and qual­i­fic­a­tions, and is in agree­ment;
c.
the pro­tec­tion of pa­tients, users and third parties is en­sured; and
d.
the ef­fic­acy and per­form­ance of the med­ic­al device are not placed at risk.

4 If re­ques­ted, ad­di­tion­al in­form­a­tion must be provided to users in one of the of­fi­cial lan­guages of Switzer­land.

5 If a product can­not be, or can­not yet be, placed on the mar­ket as a med­ic­al device but may be con­fused with such a device, the claims re­lat­ing to the said product must in­dic­ate clearly and legibly that it is not a med­ic­al device and is not suit­able for med­ic­al pur­poses.

6 Devices in­ten­ded solely for demon­stra­tion and ex­hib­i­tion pur­poses must be spe­cific­ally la­belled as such. The in­form­a­tion must be clearly vis­ible and com­pre­hens­ible.

7 Mis­lead­ing or con­tra­dict­ory in­form­a­tion on a device’s in­ten­ded pur­pose, safety and per­form­ance is for­bid­den.

23 See the foot­note to Art. 4 para. 1 let. f.

Art. 17 Unambiguous product identification  

1 Any man­u­fac­turer or nat­ur­al or leg­al per­son who as­sembles sys­tems and pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR24 shall as­sign the product, sys­tem or pro­ced­ure pack, with the ex­cep­tion of cus­tom-made devices, and all su­per­or­din­ate pack­aging lay­ers a unique device iden­ti­fi­er (UDI25) pri­or to pla­cing it on the mar­ket.26

2 It must state the UDI on the la­belling of the device, sys­tem or pro­ced­ure pack and all su­per­or­din­ate pack­aging lay­ers. Trans­port con­tain­ers are not re­garded as a su­per­or­din­ate pack­aging lay­er.27

3 It shall main­tain a list of all the UDIs it has as­signed. This list is part of the tech­nic­al doc­u­ment­a­tion spe­cified in An­nex II to EU-MDR. It must be kept up-to-date at all times.28

4 The ob­lig­a­tions and mod­al­it­ies as­so­ci­ated with product iden­ti­fic­a­tion and re­gis­tra­tion are gov­erned by Art­icles 27 and 29 and An­nex VI to EU-MDR, tak­ing ac­count of the amend­ments to this An­nex made by the European Com­mis­sion by means of del­eg­ated acts29.

5 ...30

24 See the foot­note to Art. 4 para. 1 let. f.

25 Stands for «Unique Device Iden­ti­fic­a­tion»

26 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

27 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

28 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

29 See An­nex 4.

30 To enter in­to force in due course (Art. 110 para. 2).

Section 3 Reporting Obligations and Information

Art. 18 Obligation to report the use of devices manufactured in healthcare institutions  

1 Health­care in­sti­tu­tions that man­u­fac­ture and use devices as spe­cified in Art­icle 9 shall provide the fol­low­ing in­form­a­tion to Swiss­med­ic pri­or to put­ting the devices in­to ser­vice:

a.
their name and ad­dress;
b.
the name and in­ten­ded pur­pose of the device;
c.
the risk class of the device in ac­cord­ance with Art­icle 15 para­graph 1.

2 Any oth­er rel­ev­ant in­form­a­tion about these devices must be sub­mit­ted to Swiss­med­ic at Swiss­med­ic’s re­quest. The de­clar­a­tion re­quired un­der Art­icle 5 para­graph 5 let­ter e EU-MDR31 must be made pub­licly avail­able.

3 Changes to the in­form­a­tion re­quired in para­graph 1 must be re­por­ted to Swiss­med­ic with­in 30 days.

4 De­pend­ing on the risk in­her­ent in a device and its use, Swiss­med­ic may ex­empt devices man­u­fac­tured and used in ac­cord­ance with Art­icle 9 from the re­port­ing ob­lig­a­tion.

31 See the foot­note to Art. 4 para. 1 let. f.

Art. 19 Reporting obligation for natural and legal persons who make custom-made devices available on the market  

1 Any nat­ur­al or leg­al per­son who makes cus­tom-made devices avail­able on the Swiss mar­ket must provide the fol­low­ing in­form­a­tion to Swiss­med­ic be­fore mak­ing the devices avail­able:

a.
the name and ad­dress of the man­u­fac­turer and all man­u­fac­tur­ing sites;
b.
the name and ad­dress of the au­thor­ised rep­res­ent­at­ive if ap­plic­able;
c.
the codes re­quired to identi­fy the rel­ev­ant product cat­egor­ies, as spe­cified by the European Com­mis­sion by means of im­ple­ment­ing acts32.

2 Changes to this in­form­a­tion must be re­por­ted to Swiss­med­ic with­in 30 days of the changes tak­ing ef­fect.

3 De­pend­ing on the risk in­her­ent in a device and its use, Swiss­med­ic may ex­empt cus­tom-made devices from the re­port­ing ob­lig­a­tion un­der para­graph 1.

32 See An­nex 4.

Art. 20 Information on implantable devices  

1 For im­plant­able products, the man­u­fac­turer must provide, in ad­di­tion to the product in­form­a­tion re­quired un­der Art­icle 16, the in­form­a­tion re­quired un­der Art­icle 18 para­graph 1 EU-MDR33, in­clud­ing the im­plant­a­tion cer­ti­fic­ate. The ex­emp­tions spe­cified un­der Art­icle 18 para­graph 3 EU-MDR ap­ply, tak­ing ac­count of the amend­ments ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts34.

2 The im­plant­a­tion cer­ti­fic­ate must be writ­ten in all three of­fi­cial lan­guages of Switzer­land.

3 Health­care in­sti­tu­tions must enter the de­tails of the im­plant re­cip­i­ent in the im­plant­a­tion cer­ti­fic­ate and give the cer­ti­fic­ate to the re­cip­i­ent. They provide the es­sen­tial in­form­a­tion needed by the re­cip­i­ent in a quickly ac­cess­ible form.

33 See the foot­note to Art. 4 para. 1 let. f.

34 See An­nex 4.

Chapter 3 Conformity Assessment, Certificate and Declaration

Section 1 Conformity assessment

Art. 21 Principle  

1 Any nat­ur­al or leg­al per­son who is dom­i­ciled in Switzer­land and makes devices avail­able on the mar­ket in Switzer­land or in a con­tract­ing state must, upon re­quest, provide the au­thor­it­ies re­spons­ible for con­trols as part of mar­ket mon­it­or­ing with the de­clar­a­tion of con­form­ity.

2 Any nat­ur­al or leg­al per­son who is dom­i­ciled in Switzer­land and places a device on the mar­ket in Switzer­land or in a con­tract­ing state or puts a device in­to ser­vice in Switzer­land or in a con­tract­ing state without pla­cing it on the mar­ket must carry out and be able to pro­duce doc­u­ment­ary evid­ence of an eval­u­ation of the device’s con­form­ity with the gen­er­al safety and per­form­ance re­quire­ments.

3 The demon­stra­tion of com­pli­ance with the gen­er­al safety and per­form­ance re­quire­ments must also in­clude a clin­ic­al eval­u­ation in ac­cord­ance with Art­icle 61 EU-MDR35.

35 See the foot­note to Art. 4 para. 1 let. f.

Art. 22 Exemptions  

1 In re­sponse to a jus­ti­fied ap­plic­a­tion, Swiss­med­ic may au­thor­ise the pla­cing on the mar­ket and put­ting in­to ser­vice of a spe­cif­ic device the use of which is in the in­terests of pub­lic health or pa­tient safety or health even though:

a.
the rel­ev­ant con­form­ity as­sess­ment pro­ced­ure ac­cord­ing to Art­icle 23 has not been car­ried out; or
b.
the lan­guage re­quire­ments in Art­icle 16 para­graph 2 have not been met.

2 In­di­vidu­al devices that have not un­der­gone the rel­ev­ant con­form­ity as­sess­ment pro­ced­ure may be placed on the mar­ket and used without au­thor­isa­tion from Swiss­med­ic provided:

a.
they serve to avert life-threat­en­ing con­di­tions or to re­solve the per­man­ent impair­ment of a bod­ily func­tion;
b.
no con­form­ing device is avail­able for this spe­cif­ic in­dic­a­tion;
c.
they are used ex­clus­ively by health­care pro­fes­sion­als on in­di­vidu­al per­sons;
d.
the health­care pro­fes­sion­al us­ing the device has in­formed the in­di­vidu­al con­cerned about the non-con­form­ity of the med­ic­al device and the re­lated risks; and
e.
the in­di­vidu­al con­cerned has con­sen­ted to the use of the device.

3 For devices placed on the mar­ket ex­clus­ively with­in the armed forces or with­in the frame­work of their spe­cif­ic tasks, the Fed­er­al De­part­ment of Home Af­fairs (FDHA) may, in agree­ment with the Fed­er­al De­part­ment of De­fence, Civil Pro­tec­tion and Sports, grant ex­emp­tions.

Art. 23 Procedure  

The con­form­ity as­sess­ment pro­ced­ure is gov­erned by Art­icles 52 and 54 and by An­nexes IX–XI to EU-MDR36, tak­ing ac­count of the amend­ments to Art­icle 52, para­graph 4, sub-para­graph 2 EU-MDR ad­op­ted by the European Com­mis­sion by del­eg­ated act37.

36 See the foot­note to Art. 4 para. 1 let. f.

37 See An­nex 4.

Art. 24 Involvement of a designated body  

1 When a des­ig­nated body is in­volved, all the in­form­a­tion ne­ces­sary for the con­form­ity as­sess­ment must be made avail­able to it.

2 Man­u­fac­tur­ers must not ap­ply to more than one des­ig­nated body in Switzer­land or a con­tract­ing state to con­duct a con­form­ity as­sess­ment pro­ced­ure for the same product.

3 Any nat­ur­al or leg­al per­son who ap­plies to a des­ig­nated body must in­form that body wheth­er an ap­plic­a­tion to a dif­fer­ent des­ig­nated body in Switzer­land or a con­tract­ing state has been with­drawn be­fore a de­cision was is­sued or re­jec­ted by a dif­fer­ent des­ig­nated body in Switzer­land or a con­tract­ing state.

4 If a man­u­fac­turer with­draws its ap­plic­a­tion to have a con­form­ity as­sess­ment pro­ced­ure con­duc­ted be­fore the des­ig­nated body has is­sued its de­cision on the as­sess­ment, the des­ig­nated body in ques­tion will no­ti­fy Swiss­med­ic and the oth­er des­ig­nated bod­ies.

5 The in­form­a­tion re­quired in para­graph 4 must be sup­plied ex­clus­ively via Eu­damed.

6 Where a man­u­fac­turer vol­un­tar­ily changes des­ig­nated body, it must com­ply with the re­quire­ments of Art­icle 58 EU-MDR38.

38 See the foot­note to Art. 4 para. 1 let. f.

Section 2 Certificate of Conformity

Art. 25 Issuing and content  

1 The des­ig­nated bod­ies is­sue cer­ti­fic­ates of con­form­ity in ac­cord­ance with An­nexes IX–XI to EU-MDR39 (Cer­ti­fic­ates).

2 The cer­ti­fic­ates must be is­sued in one of the three of­fi­cial lan­guages of Switzer­land or in Eng­lish.

3 They must, as a min­im­um, in­clude the in­form­a­tion re­quired in An­nex XII to EU-MDR, tak­ing ac­count of the amend­ments to this An­nex ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts40.

4 Cer­ti­fic­ates is­sued by bod­ies des­ig­nated un­der EU law and dom­i­ciled in an EU or EEA state but not re­cog­nised by an in­ter­na­tion­al agree­ment are deemed equi­val­ent to cer­ti­fic­ates is­sued by Swiss bod­ies if it can be cred­ibly demon­strated that:

a.
the con­form­ity as­sess­ment pro­ced­ures used meet Swiss re­quire­ments; and
b.
the cer­ti­fic­ates were is­sued by a body with an equi­val­ent qual­i­fic­a­tion to that re­quired in Switzer­land.41

39 See the foot­note to Art. 4 para. 1 let. f.

40 See An­nex 4.

41 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

Art. 26 Validity  

1 Cer­ti­fic­ates are val­id for a max­im­um of five years. The ex­piry date must ap­pear on the cer­ti­fic­ate.

2 At the man­u­fac­turer's re­quest, the valid­ity of the cer­ti­fic­ate can be ex­ten­ded by a max­im­um of five years fol­low­ing a new as­sess­ment car­ried out in ac­cord­ance with the rel­ev­ant con­form­ity as­sess­ment pro­ced­ure. Cer­ti­fic­ates can be ex­ten­ded more than once.

3 Any ad­dendum to a cer­ti­fic­ate is val­id for the same peri­od as the cer­ti­fic­ate to which it be­longs.

Art. 27 Suspension, restriction and revocation  

1 If a des­ig­nated body finds that a man­u­fac­turer no longer ful­fils the re­quire­ments of this Or­din­ance, it shall im­pose on that man­u­fac­turer a suit­able dead­line for restor­ing com­pli­ance.

2 If this dead­line passes without the man­u­fac­turer tak­ing suit­able cor­rect­ive ac­tion, the des­ig­nated body shall sus­pend, re­voke or re­strict the cer­ti­fic­ate in ques­tion.

3 A cer­ti­fic­ate that has been amended, sus­pen­ded or re­voked by a des­ig­nated body must no longer be used in its ori­gin­al form.

Art. 28 Documentation requirements  

1 The des­ig­nated body will provide Swiss­med­ic and the oth­er des­ig­nated bod­ies with:42

a.
all in­form­a­tion on cer­ti­fic­ates it has is­sued and any amend­ments or ad­denda to such cer­ti­fic­ates;
b.
in­form­a­tion on sus­pen­ded, re­act­iv­ated or re­voked cer­ti­fic­ates;
c.
in­form­a­tion on cer­ti­fic­ates it has re­jec­ted;
d.
in­form­a­tion on re­stric­tions im­posed on cer­ti­fic­ates.

2 It will also provide Swiss­med­ic with in­form­a­tion on wheth­er or not a con­form­ity as­sess­ment pro­ced­ure should be ap­plied in ac­cord­ance with Art­icle 54 para­graph 1 EU-MDR43. No­ti­fic­a­tions of cer­ti­fic­ates for devices that have un­der­gone a pro­ced­ure of this type must in­clude the doc­u­ments spe­cified in Art­icle 55 para­graph 1 EU-MDR.44

42 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

43 See the foot­note to Art. 4 para. 1 let. f.

44 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Section 3 Declaration of Conformity

Art. 29  

1 If the ap­plic­able con­form­ity as­sess­ment pro­ced­ure has demon­strated that the re­quire­ments of this Or­din­ance have been ful­filled, the man­u­fac­turer of devices that are not cus­tom-made or in­vest­ig­a­tion­al is­sues a de­clar­a­tion of con­form­ity. This de­clar­a­tion shall be sub­ject to on­go­ing up­dat­ing.

2 The de­clar­a­tion of con­form­ity must in­clude the in­form­a­tion re­quired in An­nex IV to EU-MDR45, tak­ing ac­count of the amend­ments to this An­nex ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts46. It must be writ­ten in one of the three of­fi­cial lan­guages of Switzer­land or Eng­lish or trans­lated in­to one of these lan­guages.

3 If a device also re­quires a man­u­fac­turer's de­clar­a­tion of con­form­ity for as­pects not covered by this Or­din­ance but nev­er­the­less re­quired by oth­er le­gis­la­tion in or­der to demon­strate com­pli­ance with that le­gis­la­tion, one single de­clar­a­tion of con­form­ity will be is­sued.

4 By is­su­ing the de­clar­a­tion of con­form­ity, the man­u­fac­turer as­sumes re­spons­ib­il­ity for en­sur­ing that the device com­plies with the re­quire­ments of this Or­din­ance as well as with any oth­er le­gis­la­tion to which the device is sub­ject.

45 See the foot­note to Art. 4 para. 1 let. f.

46 See An­nex 4.

Chapter 4 Requirements applicable to Tissues and Cells of Human Origin that are incorporated into or used in the Production of Devices

Art. 30 Establishment licence  

1 An es­tab­lish­ment li­cence is­sued by Swiss­med­ic is re­quired by any nat­ur­al or leg­al per­son who:

a.
re­moves tis­sue or cells from hu­mans for the pur­pose of de­vi­tal­ising the tis­sue or cells and us­ing them to man­u­fac­ture devices or sup­ply­ing them for use in device man­u­fac­ture;
b.
stores tis­sue or cells re­moved for the pur­poses in let­ter a;
c.
im­ports or ex­ports tis­sue or cells re­moved for the pur­poses in let­ter a.

2 A li­cence shall be is­sued if:

a.
the re­quire­ments in terms of pro­fes­sion­al qual­i­fic­a­tions and op­er­a­tion­al in­fra­struc­ture are ful­filled;
b.
a qual­ity as­sur­ance sys­tem that com­plies with cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards is in place;
c.
the fa­cil­ity has a Re­spons­ible Per­son with the ne­ces­sary spe­cial­ist know­ledge, ex­per­i­ence and dir­ect­ive au­thor­ity in their area of re­spons­ib­il­ity and who is re­spons­ible for qual­ity;
d.
the ob­lig­a­tions spe­cified in Art­icles 31 and 32 are ful­filled.

3 Swiss­med­ic shall veri­fy that the con­di­tions for is­su­ing an es­tab­lish­ment li­cence are ful­filled in the course of an in­spec­tion.

4 Art­icles 39–43 of the Medi­cin­al Products Li­cens­ing Or­din­ance of 14 Novem­ber 201847 (MPLO) also ap­ply.

Art. 31 Collection, donation and testing  

1 The re­quire­ments of Art­icles 3, 4, 6–15 and 30–33 of the Trans­plant­a­tion Act of 8 Oc­to­ber 200448 and of Art­icles 2–12 of the Trans­plant­a­tion Or­din­ance of 16 March 200749 ap­ply mu­tatis mutandis to col­lec­tion, dona­tion and test­ing.

2 Hold­ers of an es­tab­lish­ment li­cence is­sued un­der Art­icle 30 must veri­fy the suit­ab­il­ity of donors.

Art. 32 Duty to keep records and traceability  

1 It must be pos­sible to trace all tis­sue and cells har­ves­ted from hu­mans for the pur­pose of de­vi­tal­isa­tion and use in devices from the donor to the re­cip­i­ent and vice versa. Art. 35, para­graphs 1 and 2, MPLO50 also ap­ply.

2 Moreover, the pro­vi­sions of Art­icles 34 and 35 of the Trans­plant­a­tion Act of 8 Oc­to­ber 200451 ap­ply mu­tatis mutandis to trace­ab­il­ity.

Chapter 5 Designated Bodies

Section 1 Designation

Art. 33 Requirements and application  

1 Swiss­med­ic will only des­ig­nate con­form­ity as­sess­ment bod­ies that have com­pleted an as­sess­ment pro­ced­ure in ac­cord­ance with Art­icle 34 and which sat­is­fy the re­quire­ments set out in An­nex VII to EU-MDR52.

2 Ap­plic­a­tions for des­ig­na­tion must be sub­mit­ted to Swiss­med­ic. They must in par­tic­u­lar in­clude:

a.
de­tails of the activ­it­ies and the types of product for which des­ig­na­tion is sought;
b.
proof that the re­quire­ments of An­nex VII to EU-MDR are met.

3 Swiss­med­ic shall veri­fy wheth­er the ap­plic­a­tion for des­ig­na­tion is com­plete with­in thirty days, and re­quest the ap­plic­ant to sub­mit any in­form­a­tion that may be miss­ing.

4 It shall re­view the ap­plic­a­tion and ac­com­pa­ny­ing doc­u­ments and is­sue a pre­lim­in­ary as­sess­ment re­port.

52 See the foot­note to Art. 4 para. 1 let. f.

Art. 34 Assessment  

1 Swiss­med­ic shall con­duct an on-site as­sess­ment of the con­form­ity as­sess­ment body and, if rel­ev­ant, of all sub-con­tract­ors and sub­si­di­ar­ies.

2 If Swiss­med­ic iden­ti­fies non-com­pli­ances in the course of its as­sess­ment, it shall draw up a list of non-com­pli­ances for the ap­plic­ant. Swiss­med­ic shall set the con­form­ity as­sess­ment body a dead­line by which the lat­ter must sub­mit to Swiss­med­ic a cor­rect­ive ac­tion plan to rem­edy the non-com­pli­ances and a plan set­ting out pre­vent­ive meas­ures.

3 The plans must in­dic­ate the root cause of the iden­ti­fied non-com­pli­ances and must in­clude a time­frame for im­ple­ment­ing the meas­ures.

4 Swiss­med­ic will de­cide wheth­er the pro­posed ac­tion is suit­able and wheth­er the time­frame for im­ple­ment­a­tion is ap­pro­pri­ate.

Art. 35 Assessment report  

1 If Swiss­med­ic ap­proves the plans re­quired un­der Art­icle 34 para­graph 2, it shall pre­pare an as­sess­ment re­port.

2 This shall com­prise the fol­low­ing:

a.
the res­ult of the as­sess­ment;
b.
con­firm­a­tion that suit­able cor­rect­ive and pre­vent­ive meas­ures have been planned and where ne­ces­sary im­ple­men­ted;
c.
the scope of the des­ig­na­tion.
Art. 36 Issue and extension of designation  

1 Swiss­med­ic shall grant the des­ig­na­tion if the con­form­ity as­sess­ment body meets the re­quire­ments.

2 The ex­ten­sion of des­ig­na­tions is sub­ject to the re­quire­ments and pro­ced­ures laid out in Art­icles 33–35.

Art. 37 Sub-contractors and subsidiaries  

1 Des­ig­nated bod­ies that del­eg­ate part of the work to sub-con­tract­ors or to a sub­si­di­ary bear full re­spons­ib­il­ity for the work car­ried out on their be­half by the sub-con­tract­or or by the sub­si­di­ary.

2 They must en­sure that the sub-con­tract­or or the sub­si­di­ary meets the ap­plic­able re­quire­ments of An­nex VII to EU-MDR53.

3 They must no­ti­fy Swiss­med­ic if they del­eg­ate work un­der the terms of para­graph 1. They must be able to demon­strate to Swiss­med­ic that the sub-con­tract­or or the sub­si­di­ary is cap­able of car­ry­ing out the tasks as­signed to it.

4 Work may only be del­eg­ated if the des­ig­nated body has no­ti­fied the nat­ur­al or leg­al per­son who re­ques­ted the con­form­ity as­sess­ment ac­cord­ingly.

5 The des­ig­nated bod­ies must pub­lish a list of their sub­si­di­ar­ies.

53 See the foot­note to Art. 4 para. 1 let. f.

Art. 38 Duty of cooperation and notification requirement  

1 The des­ig­nated bod­ies, in­clud­ing their sub­si­di­ar­ies and sub-con­tract­ors, are re­quired to keep avail­able for Swiss­med­ic at all times all data that is ne­ces­sary for as­sess­ment, des­ig­na­tion, mon­it­or­ing and re-as­sess­ment, in­clud­ing the doc­u­ments re­quired to as­sess the qual­i­fic­a­tions of sub-con­tract­ors or sub­si­di­ar­ies. The data must be kept up-to-date at all times.

2 The des­ig­nated bod­ies shall no­ti­fy Swiss­med­ic with­in 15 days of any change that af­fects their abil­ity to meet the re­quire­ments of An­nex VII to EU-MDR54 or to carry out con­form­ity as­sess­ments.

54 See the foot­note to Art. 4 para. 1 let. f.

Art. 39 Tariffs  

The des­ig­nated bod­ies shall is­sue lists of the stand­ard tar­iffs charged for their activ­it­ies and make these lists pub­licly ac­cess­ible.

Section 2 Cessation of Conformity Assessment Activities

Art. 40  

1 If a des­ig­nated body ceases to carry out its con­form­ity as­sess­ment activ­it­ies, it shall no­ti­fy Swiss­med­ic and the man­u­fac­tur­ers con­cerned as soon as pos­sible. In the case of planned ces­sa­tion of activ­it­ies, no­tice must be giv­en one year be­fore the activ­it­ies cease. Swiss­med­ic will re­voke the des­ig­na­tion from the date on which the activ­it­ies cease.

2 The cer­ti­fic­ates will re­main val­id for a max­im­um of nine months fol­low­ing ces­sa­tion of activ­it­ies, provided an­oth­er des­ig­nated body as­sumes re­spons­ib­il­ity for cer­ti­fy­ing the products con­cerned and con­firms this in writ­ing.

3 The des­ig­nated body as­sum­ing re­spons­ib­il­ity in ac­cord­ance with para­graph 2 shall con­duct a full as­sess­ment of the products con­cerned be­fore the nine-month peri­od ex­pires and be­fore is­su­ing new cer­ti­fic­ates for the products.

Section 3 Suspension, Restriction or Revocation of Designation

Art. 41 Principle  

1 Des­ig­na­tion shall be sus­pen­ded, re­stric­ted or re­voked if the des­ig­nated body:

a.
no longer or only partly meets the re­quire­ments; or
b.
fails to carry out cor­rect­ive ac­tion ordered by Swiss­med­ic.

2 Sus­pen­sions will be im­posed for a max­im­um of twelve months. They may be ex­ten­ded by a max­im­um of a fur­ther twelve months.

3 If des­ig­na­tion is sus­pen­ded, re­stric­ted or re­voked, the des­ig­nated body must in­form all af­fected man­u­fac­tur­ers ac­cord­ingly with­in ten days.

Art. 42 Unduly issued certificates  

1 In the event of its des­ig­na­tion be­ing re­stric­ted, sus­pen­ded or re­voked, the des­ig­nated body will sus­pend or with­draw any cer­ti­fic­ates which were un­duly is­sued.

2 If the des­ig­nated body fails to ful­fil this re­quire­ment, Swiss­med­ic will in­struct it to sus­pend or re­voke the cer­ti­fic­ates and set an ap­pro­pri­ate dead­line for do­ing so.

Art. 43 Validity of certificates in the event of suspension or restriction of designation  

1 If Swiss­med­ic sus­pends or re­stricts the des­ig­na­tion of a des­ig­nated body, the cer­ti­fic­ates con­cerned re­main val­id provided Swiss­med­ic:

a.
con­firms with­in a month that no safety is­sue ex­ists in con­nec­tion with the products con­cerned; and
b.
out­lines a timeline and meas­ures to rem­edy the sus­pen­sion or re­stric­tion.

2 The cer­ti­fic­ates also re­main val­id if Swiss­med­ic:

a.
con­firms that, dur­ing the sus­pen­sion or re­stric­tion, no cer­ti­fic­ates rel­ev­ant to the sus­pen­sion will be is­sued, amended or re-is­sued; and
b.
states that the des­ig­nated body is able to con­tin­ue to mon­it­or and re­tain re­spons­ib­il­ity for ex­ist­ing cer­ti­fic­ates dur­ing the sus­pen­sion or re­stric­tion.

3 The des­ig­nated body shall no­ti­fy the man­u­fac­tur­ers con­cerned or the per­sons or en­tit­ies pla­cing the devices con­cerned on the mar­ket.

4 Should Swiss­med­ic as­cer­tain that the des­ig­nated body is un­able to con­tin­ue to over­see ex­ist­ing cer­ti­fic­ates, these cer­ti­fic­ates will re­tain their valid­ity if the man­u­fac­turer of the product in ques­tion con­firms to Swiss­med­ic or, if it is dom­i­ciled in a con­tract­ing state, to the com­pet­ent au­thor­ity there, in writ­ing and with­in three months of des­ig­na­tion be­ing sus­pen­ded or re­stric­ted that:

a.
an­oth­er qual­i­fied des­ig­nated body is tem­por­ar­ily as­sum­ing the over­sight du­ties; and
b.
this des­ig­nated body will be re­spons­ible for the cer­ti­fic­ates dur­ing the peri­od of sus­pen­sion or re­stric­tion.
Art. 44 Validity of certificates in the event of designation being revoked  

1 If Swiss­med­ic re­vokes the des­ig­na­tion of a des­ig­nated body, the cer­ti­fic­ates af­fected re­main val­id for nine months provided:

a.
Swiss­med­ic or, if the man­u­fac­turer is dom­i­ciled in a con­tract­ing state, the com­pet­ent au­thor­ity there con­firms that the products in ques­tion present no safety is­sues;
b.
an­oth­er des­ig­nated body con­firms in writ­ing that it is as­sum­ing im­me­di­ate re­spons­ib­il­ity for the cer­ti­fic­ates for these products and can com­plete the as­sess­ment of the products with­in twelve months of des­ig­na­tion be­ing re­voked.

2 Swiss­med­ic may, with­in the lim­its of its com­pet­ence, ex­tend the pro­vi­sion­al valid­ity of the cer­ti­fic­ates for fur­ther peri­ods of three months, which al­to­geth­er must not ex­ceed twelve months.

Section 4 Monitoring and Re-assessment of Designated Bodies

Art. 45  

1 Swiss­med­ic shall mon­it­or the des­ig­nated bod­ies and their sub­si­di­ar­ies and sub-con­tract­ors and carry out re-as­sess­ments. In the course of mon­it­or­ing and re-as­sess­ing des­ig­nated bod­ies and re­view­ing their as­sess­ments, Swiss­med­ic shall take ac­count of the re­quire­ments and pro­ced­ures set out in Art­icles 44 and 45 EU-MDR55.

2 It will veri­fy wheth­er des­ig­nated bod­ies still sat­is­fy the re­quire­ments of Art­icle 36 para­graph 1 and An­nex VII to EU-MDR three years after des­ig­na­tion, and then every four years, in the course of a full re-as­sess­ment. This pro­vi­sion is sub­ject to changes in as­sess­ment in­ter­vals res­ult­ing from del­eg­ated acts56 is­sued by the European Com­mis­sion.

3 Swiss­med­ic will carry out an on-the-spot as­sess­ment at least once a year to as­cer­tain wheth­er the des­ig­nated bod­ies and, if ap­plic­able, their sub­si­di­ar­ies and sub-con­tract­ors are ful­filling the re­quire­ments and ob­lig­a­tions of An­nex VII to EU-MDR.

4 For this pur­pose, it may at any time:

a.
carry out on-site as­sess­ments with or without ad­vance no­tice;
b.
carry out audits of the em­ploy­ees of the des­ig­nated body and its sub­si­di­ar­ies or sub-con­tract­ors or ob­serve audits that the des­ig­nated body car­ries out on man­u­fac­tur­ers’ premises.

55 See the foot­note to Art. 4 para. 1 let. f.

56 See An­nex 4.

Chapter 6 Requirements for Economic Operators

Section 1 Manufacturers

Art. 46 Conformity marking and clinical evaluation  

1 Man­u­fac­tur­ers guar­an­tee that their products have been de­signed and man­u­fac­tured in ac­cord­ance with the re­quire­ments of this Or­din­ance when they place them on the mar­ket or put them in­to ser­vice.

2 They must print the con­form­ity mark­ing on their products.

3 They must con­duct a clin­ic­al eval­u­ation in ac­cord­ance with Art­icle 61 EU-MDR57 tak­ing ac­count of the amend­ments to this Art­icle ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts58 and in ac­cord­ance with An­nex XIV to EU-MDR. They must up­date this clin­ic­al eval­u­ation in line with the res­ults of post-mar­ket clin­ic­al fol­low-up.

57 See the foot­note to Art. 4 para. 1 let. f.

58 See An­nex 4.

Art. 47 Technical documentation  

1 Man­u­fac­tur­ers must list in the tech­nic­al doc­u­ment­a­tion the in­form­a­tionre­quired in An­nexes II and III to EU-MDR59, tak­ing ac­count of the amend­ments to these An­nexes made by the European Com­mis­sion by means of del­eg­ated acts60.

2 Man­u­fac­tur­ers must sub­mit either the com­plete tech­nic­al doc­u­ment­a­tion or a sum­mary of this doc­u­ment­a­tion when re­ques­ted to do so by the com­pet­ent au­thor­ity.

59 See the foot­note to Art. 4 para. 1 let. f.

60 See An­nex 4.

Art. 48 Document retention requirements  

1 Man­u­fac­tur­ers must en­sure that the fol­low­ing are avail­able to the com­pet­ent au­thor­ity for at least ten years after the fi­nal product covered by the de­clar­a­tion of con­form­ity has been placed on the mar­ket:

a.
com­plete tech­nic­al doc­u­ment­a­tion;
b.
de­clar­a­tion of con­form­ity;
c.
a copy of the cer­ti­fic­ates is­sued, in­clud­ing any amend­ments and ad­denda.

2 The doc­u­ment re­ten­tion peri­od for im­plant­able products shall be at least 15 years from the date the last product was placed on the mar­ket.

Art. 49 Person responsible for regulatory compliance  

1 Man­u­fac­tur­ers must have avail­able with­in their or­gan­isa­tion at least one per­son re­spons­ible for reg­u­lat­ory com­pli­ance who pos­sesses the re­quis­ite ex­pert­ise in the field of med­ic­al devices.

2 Proof that the per­son re­spons­ible for reg­u­lat­ory com­pli­ance pos­sesses the re­quis­ite ex­pert­ise, the re­spons­ib­il­it­ies of this per­son, ex­cep­tions and fur­ther mod­al­it­ies are gov­erned by Art­icle 15 EU-MDR61.

3 The per­son re­spons­ible for reg­u­lat­ory com­pli­ance must have a deputy. If a num­ber of per­sons are jointly re­spons­ible for reg­u­lat­ory com­pli­ance, their re­spect­ive areas of re­spons­ib­il­ity shall be stip­u­lated in writ­ing.

4 The per­son re­spons­ible for reg­u­lat­ory com­pli­ance must suf­fer no dis­ad­vant­age with­in the man­u­fac­turer's or­gan­isa­tion in re­la­tion to the prop­er ful­fil­ment of their du­ties, re­gard­less of wheth­er or not they are em­ploy­ees of the or­gan­isa­tion.

61 See the foot­note to Art. 4 para. 1 let. f.

Art. 50 Further obligations  

The fur­ther ob­lig­a­tions in­cum­bent on man­u­fac­tur­ers, par­tic­u­larly the re­quire­ments to be ful­filled by their qual­ity and risk man­age­ment sys­tems, are gov­erned by Art­icle 10 EU-MDR62.

62 See the foot­note to Art. 4 para. 1 let. f.

Section 2 Authorised Representative

Art. 51 Obligations  

1 Where the man­u­fac­turer of a device is not dom­i­ciled in Switzer­land, the device may only be placed on the mar­ket if the man­u­fac­turer des­ig­nates an au­thor­ised rep­res­ent­at­ive dom­i­ciled in Switzer­land by means of a writ­ten man­date.

2 The au­thor­ised rep­res­ent­at­ive is re­spons­ible for the form­al and safety-re­lated as­pects of pla­cing the device on the mar­ket.

3 The au­thor­ised rep­res­ent­at­ive’s rights and ob­lig­a­tions and the scope of its man­date are gov­erned by Art­icle 11 EU-MDR63.

3bis The man­u­fac­turer and au­thor­ised rep­res­ent­at­ive may con­trac­tu­ally agree that in­stead of the au­thor­ised rep­res­ent­at­ive keep­ing avail­able a copy of the tech­nic­al doc­u­ment­a­tion, the man­u­fac­turer shall, on re­quest, sub­mit the doc­u­ment­a­tion straight to Swiss­med­ic. The au­thor­ised rep­res­ent­at­ive must en­sure that the doc­u­ment­a­tion is sub­mit­ted with­in sev­en days.64

4 Changes in au­thor­ised rep­res­ent­at­ive are gov­erned by Art­icle 12 EU-MDR.

5 Para­graphs 1–4 also ap­ply to nat­ur­al or leg­al per­sons who as­semble sys­tems and pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR and who are not dom­i­ciled in Switzer­land.65

63 See the foot­note to Art. 4 para. 1 let. f.

64 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

65 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

Art. 52 Person responsible for regulatory compliance  

1 Au­thor­ised rep­res­ent­at­ives must en­sure that they have per­man­ently and con­tinu­ously at their dis­pos­al at least one per­son who pos­sesses the re­quis­ite ex­pert­ise as re­gards the re­quire­ments for med­ic­al devices un­der this Or­din­ance and who is re­spons­ible for reg­u­lat­ory com­pli­ance.

2 In oth­er re­spects, Art­icle 49 para­graphs 2–4 shall ap­ply.

Section 3 Importers

Art. 53  

1 Im­port­ers may only place on the mar­ket devices that com­ply with this Or­din­ance. Be­fore pla­cing devices on the mar­ket, they shall veri­fy that:

a.
the device car­ries the con­form­ity mark­ing;
b.
the de­clar­a­tion of con­form­ity has been drawn up;
c.
the man­u­fac­turer is iden­ti­fied and has des­ig­nated an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51;
d.
the product is la­belled in ac­cord­ance with this Or­din­ance and ac­com­pan­ied by in­struc­tions for use;
e.
the man­u­fac­turer has as­signed a UDI where ap­plic­able.

2 Im­port­ers must print their name, place of busi­ness and con­tact ad­dress on the product, the product pack­aging or a doc­u­ment en­closed with the product.

3 Where an im­port­er con­siders or has reas­on to be­lieve that a device is not in con­form­ity with the re­quire­ments of this Or­din­ance, it must not place the device on the mar­ket un­til it has been brought in­to con­form­ity.

4 The fur­ther ob­lig­a­tions of im­port­ers pri­or to and after pla­cing a device on the mar­ket are gov­erned by Art­icles 13 and 16 para­graphs 3 and 4 EU-MDR66. In par­tic­u­lar, im­port­ers must com­ply with the fol­low­ing ob­lig­a­tions:

a.
stor­age, trans­port and qual­ity man­age­ment sys­tem;
b.
co­oper­a­tion with the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, des­ig­nated body and com­pet­ent au­thor­it­ies;
c.
the pro­vi­sion of in­form­a­tion to the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, des­ig­nated body and com­pet­ent au­thor­it­ies.

66 See the foot­note to Art. 4 para. 1 let. f.

Section 4 Distributors

Art. 54  

1 When mak­ing a device avail­able on the mar­ket, dis­trib­ut­ors must, in the con­text of their activ­it­ies, act with due care in re­la­tion to the re­quire­ments ap­plic­able. Be­fore mak­ing a device avail­able on the mar­ket, dis­trib­ut­ors must veri­fy that:

a.
the device car­ries the con­form­ity mark­ing;
b.
the de­clar­a­tion of con­form­ity has been drawn up;
c.
the device is ac­com­pan­ied by product in­form­a­tion;
d.
where devices have been im­por­ted the im­port­er has provided the in­form­a­tion re­quired in Art­icle 53 para­graph 2;
e.
the man­u­fac­turer has as­signed a UDI where ap­plic­able.

2 With the ex­cep­tion of para­graph 1 let­ter d, ran­dom sampling may be used for the pur­poses of veri­fic­a­tion.

3 Where a dis­trib­ut­or con­siders or has reas­on to be­lieve that a device is not in con­form­ity with the re­quire­ments of this Or­din­ance, it must not make the device avail­able on the mar­ket un­til it has been brought in­to con­form­ity.

4 The fur­ther ob­lig­a­tions of dis­trib­ut­ors pri­or to and after mak­ing a device avail­able on the mar­ket are gov­erned by Art­icles 14 and 16 para­graphs 3 and 4 EU-MDR67. In par­tic­u­lar, dis­trib­ut­ors must ful­fil the fol­low­ing ob­lig­a­tions:

a.
stor­age, trans­port and qual­ity man­age­ment sys­tem;
b.
co­oper­a­tion with the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er and com­pet­ent au­thor­it­ies;
c.
the pro­vi­sion of in­form­a­tion to the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er and com­pet­ent au­thor­it­ies.

67 See the foot­note to Art. 4 para. 1 let. f.

Section 5 Registration of Economic Operators68

68 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Art. 55  

1 Man­u­fac­tur­ers or their au­thor­ised rep­res­ent­at­ives and im­port­ers must re­gister the in­form­a­tion re­quired by part A of An­nex VI to EU-MDR69 with Swiss­med­ic with­in three months of pla­cing a device on the mar­ket for the first time.

2 The eco­nom­ic op­er­at­or in ques­tion must re­port any changes to the in­form­a­tion to Swiss­med­ic with­in one week.

3 Fur­ther ob­lig­a­tions and re­gis­tra­tion mod­al­it­ies are gov­erned by Art­icles 30 para­graph 3 and 31 EU-MDR.

4 Swiss­med­ic will veri­fy the in­form­a­tion provided by the eco­nom­ic op­er­at­ors and as­sign them a unique iden­ti­fic­a­tion num­ber.

5 Any nat­ur­al or leg­al per­son pla­cing sys­tems and pro­ced­ure packs on the mar­ket for the first time un­der Art­icle 11 must re­gister their name and the ad­dress at which they can be con­tac­ted with Swiss­med­ic with­in three months of pla­cing the sys­tem or pro­ced­ure pack on the mar­ket. Where an au­thor­ised rep­res­ent­at­ive is re­quired un­der Art­icle 51 para­graph 5,the name and ad­dress of the au­thor­ised rep­res­ent­at­ive must also be re­gistered with Swiss­med­ic.

69 See the foot­note to Art. 4 para. 1 let. f.

Chapter 7 Device Surveillance

Section 1 Post-market Surveillance

Art. 56 System  

1 For each device, man­u­fac­tur­ers must plan, es­tab­lish, doc­u­ment, im­ple­ment, main­tain and up­date a post-mar­ket sur­veil­lance sys­tem in a man­ner that is pro­por­tion­ate to the risk class and ap­pro­pri­ate for the type of device. This sys­tem forms an in­teg­ral part of the man­u­fac­turer's qual­ity man­age­ment sys­tem.

2 The sys­tem must be suited to act­ively and sys­tem­at­ic­ally gath­er­ing, re­cord­ing and ana­lys­ing rel­ev­ant data on the qual­ity, per­form­ance and safety of a device throughout its en­tire life­time, and to draw­ing the ne­ces­sary con­clu­sions and to de­term­in­ing, im­ple­ment­ing and mon­it­or­ing any pre­vent­ive and cor­rect­ive ac­tions.

3 The mod­al­it­ies of the sys­tem, par­tic­u­larly the res­ult­ing ac­tions, up­dates and amend­ments to tech­nic­al doc­u­ment­a­tion, are gov­erned by Art­icle 83 para­graph 3 EU-MDR70.

70 See the foot­note to Art. 4 para. 1 let. f.

Art. 57 Incidents and actions  

1 Should it be­come evid­ent in the course of post-mar­ket sur­veil­lance that pre­vent­ive and/or cor­rect­ive ac­tion is ne­ces­sary, man­u­fac­tur­ers must take suit­able steps, no­ti­fy­ing the com­pet­ent au­thor­it­ies and, if ap­plic­able, the des­ig­nated body.

2 If a man­u­fac­turer be­comes aware of a ser­i­ous in­cid­ent in con­nec­tion with a device that has been made avail­able on the mar­ket, or takes ac­tion to pre­vent or min­im­ise the risk of such an in­cid­ent for med­ic­al or tech­nic­al reas­ons (field safety cor­rect­ive ac­tions), it must re­port the fact in ac­cord­ance with Art­icle 66.

Art. 58 Plan  

The post-mar­ket sur­veil­lance plan must sat­is­fy the re­quire­ments of Sec­tion 1 of An­nex III to EU-MDR71. With the ex­cep­tion of cus­tom-made devices, the plan is part of the tech­nic­al doc­u­ment­a­tion spe­cified in An­nex II to EU-MDR.

71 See the foot­note to Art. 4 para. 1 let. f.

Art. 59 Report  

1 Man­u­fac­tur­ers of class I devices must draw up a re­port on post-mar­ket sur­veil­lance.

2 This re­port must con­tain:

a.
a sum­mary of the res­ults and con­clu­sions of the ana­lyses of the data gathered as a res­ult of the plan spe­cified in Art­icle 58;
b.
a ra­tionale and de­scrip­tion of any pre­vent­ive and cor­rect­ive ac­tions taken.

3 The re­port forms part of the post-mar­ket sur­veil­lance tech­nic­al doc­u­ment­a­tion spe­cified in An­nex III to EU-MDR72.

4 The man­u­fac­turer must up­date the re­port when ne­ces­sary and make it avail­able to the com­pet­ent au­thor­ity upon re­quest.

72 See the foot­note to Art. 4 para. 1 let. f.

Section 2 Safety Report

Art. 60 Obligation  

1 Man­u­fac­tur­ers of class IIa, class IIb and class III devices shall pre­pare a safety re­port for each device and where rel­ev­ant for each cat­egory or group of devices.

2 Man­u­fac­tur­ers of class IIa devices shall up­date the safety re­port when ne­ces­sary and at least every two years. Man­u­fac­tur­ers of class IIb and class III devices must up­date this re­port at least an­nu­ally.

Art. 61 Content  

1 The safety re­port must con­tain:

a.
a sum­mary of the res­ults and con­clu­sions of the ana­lyses of the post-mar­ket sur­veil­lance data gathered as a res­ult of the post-mar­ket sur­veil­lance plan as spe­cified in Art­icle 58;
b.
a ra­tionale and de­scrip­tion of any pre­vent­ive and cor­rect­ive ac­tions taken.

2 Throughout the life­time of the device con­cerned, the safety re­port must set out:

a.
the con­clu­sions of the be­ne­fit-risk de­term­in­a­tion;
b.
the key res­ults of post-mar­ket clin­ic­al fol­low-up;
c.
the total sales volume of the device;
d.
an es­tim­ate of the size of the pop­u­la­tion us­ing the device;
e.
char­ac­ter­ist­ics of the pop­u­la­tion in let­ter d;
f.
the fre­quency of device us­age, where prac­tic­able.

3 The safety re­port forms part of the tech­nic­al doc­u­ment­a­tion spe­cified in An­nexes II and III to EU-MDR73. For cus­tom-made devices, the re­port forms part of the doc­u­ment­a­tion spe­cified in Sec­tion 2 of An­nex XIII to EU-MDR.

73 See the foot­note to Art. 4 para. 1 let. f.

Art. 62 Review 74  

1 Man­u­fac­tur­ers will make their safety re­ports avail­able to the des­ig­nated body in­volved in the con­form­ity as­sess­ment.

2 The des­ig­nated body will re­view the safety re­port for class III devices or im­plant­able devices and re­cord the out­come of its re­view with de­tails of any ac­tion taken.

3 Man­u­fac­tur­ers or their au­thor­ised rep­res­ent­at­ives will, upon re­quest, make the safety re­port and the out­come of the des­ig­nated body’s re­view, with de­tails of any ac­tion taken, avail­able to the com­pet­ent au­thor­ity.

74 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Section 3 Summary of Safety and Clinical Performance

Art. 63  

1 For class III devices and for im­plant­able devices, oth­er than cus­tom-made or in­vest­ig­a­tion­al devices, the man­u­fac­turer must draw up a sum­mary of safety and clin­ic­al per­form­ance.

2 The sum­mary of safety and clin­ic­al per­form­ance shall be writ­ten in a way that is clear to the in­ten­ded user and, if rel­ev­ant, to the pa­tient.

3 The min­im­um con­tent of the sum­mary is gov­erned by Art­icle 32, Para­graph 32 EU-MDR75.

4 The draft sum­mary of safety and clin­ic­al per­form­ance must be sub­mit­ted to the des­ig­nated body in­volved in the con­form­ity as­sess­ment pur­su­ant to Art­icle 24 for val­id­a­tion by that body.

5 The man­u­fac­turer will pub­lish the sum­mary after it has been val­id­ated.76

6 The man­u­fac­turer must men­tion on the la­bel or in­struc­tions for use where the sum­mary is avail­able.

75 See the foot­note to Art. 4 para. 1 let. f.

76 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Section 4 Traceability and Recording of Product Identification

Art. 64 Traceability  

1 Dis­trib­ut­ors and im­port­ers shall co-op­er­ate with man­u­fac­tur­ers or au­thor­ised rep­res­ent­at­ives to achieve an ap­pro­pri­ate level of trace­ab­il­ity of devices.

2 The duty of dis­clos­ure un­der Art­icle 47c TPA con­tin­ues for at least 10 years, or for at least 15 years for im­plant­able products, after the last product covered by the con­form­ity as­sess­ment was placed on the mar­ket.

Art. 65 Recording the UDI  

1 Eco­nom­ic op­er­at­ors shall store and keep, prefer­ably by elec­tron­ic means, the UDI of the class III im­plant­able devices which they have sup­plied or with which they have been sup­plied.

2 Swiss­med­ic may ex­tend this ob­lig­a­tion to oth­er devices, or cat­egor­ies or groups of devices.

Section 5 Vigilance

Art. 66 Reporting obligation  

1 Man­u­fac­tur­ers of devices made avail­able in Switzer­land or nat­ur­al or leg­al per­sons who as­semble sys­tems or pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR77 must re­port to Swiss­med­ic:

a.
any ser­i­ous in­cid­ents in­volving the device in ques­tion that have oc­curred in Switzer­land, as soon as they be­come aware of them;
b.
any field safety cor­rect­ive ac­tions un­der­taken in Switzer­land.78

2 Ex­emp­tions from this re­port­ing ob­lig­a­tion, mod­al­it­ies, peri­od­ic sum­mary re­ports, trend re­port­ing and ana­lyses of ser­i­ous in­cid­ents and field safety cor­rect­ive ac­tion are gov­erned by Art­icles 27 para­graph 5 and 87–89 EU-MDR.

2bis Where an au­thor­ised rep­res­ent­at­ive is re­quired pur­su­ant to Art­icle 51, this rep­res­ent­at­ive is re­spons­ible for the re­port­ing ob­lig­a­tion in para­graph 1. Fur­ther­more, the au­thor­ised rep­res­ent­at­ive must sub­mit the trend re­ports pur­su­ant to para­graph 2 on in­cid­ents in Switzer­land and abroad to Swiss­med­ic without be­ing re­ques­ted to do so. Fi­nal re­ports pre­pared in ac­cord­ance with Art­icle 89 para­graph 5 EU-MDR should be sub­mit­ted to Swiss­med­ic. The trans­fer of these ob­lig­a­tions from the man­u­fac­turer or from the nat­ur­al or leg­al per­son as­sem­bling sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR to the au­thor­ised rep­res­ent­at­ive must be agreed in writ­ing in the man­date.79

3 ...80

4 Any pro­fes­sion­al who be­comes aware of an in­cid­ent when us­ing devices must re­port this to the sup­pli­er and Swiss­med­ic. The re­port may be sub­mit­ted by a pro­fes­sion­al as­so­ci­ation. The timelines for do­ing so are as set out in Art­icle 87 EU-MDR.

5 Re­ports must be sub­mit­ted to Swiss­med­ic elec­tron­ic­ally and in ma­chine-read­able format. Swiss­med­ic pub­lishes in­form­a­tion on elec­tron­ic sub­mis­sion and the forms to be used with con­tent spe­cific­a­tions.

77 See the foot­note to Art. 4 para. 1 let. f.

78 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

79 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

80 Re­pealed by No I of the O of 19 May 2021, with ef­fect from 26 May 2021 (AS 2021 281).

Art. 67 Reporting systems in hospitals  

1 Hos­pit­als must set up an in­tern­al re­port­ing sys­tem with­in the frame­work of an es­tab­lished qual­ity man­age­ment sys­tem for the pur­pose of re­port­ing un­der Art­icle 66 para­graph 4.

2 They must des­ig­nate a suit­able com­pet­ent per­son (vi­gil­ance con­tact per­son) with a med­ic­al or tech­nic­al qual­i­fic­a­tion to as­sume re­spons­ib­il­ity for re­port­ing to Swiss­med­ic. They must sup­ply this per­son’s con­tact de­tails to Swiss­med­ic.

3 Re­cords and all doc­u­ments cre­ated un­der the vi­gil­ance qual­ity man­age­ment sys­tem must be re­tained for at least 15 years.

Chapter 8 Conduct in relation to Devices

Art. 68 Supply  

Devices are sup­plied in ac­cord­ance with their in­ten­ded pur­pose and the in­form­a­tion provided by the man­u­fac­turer.

Art. 69 Advertising  

1 Claims for products must only con­tain state­ments that cor­res­pond to the product in­form­a­tion.

2 Mis­lead­ing state­ments, par­tic­u­larly con­cern­ing the in­ten­ded pur­pose, safety and per­form­ance of a device, are pro­hib­ited.

3 Devices in­ten­ded solely for use by pro­fes­sion­als must not be ad­vert­ised to the pub­lic.

Art. 70 Use by professionals  

1 Any pro­fes­sion­al who uses a device from a for­eign coun­try without pla­cing it on the mar­ket is re­spons­ible for the con­form­ity of that device.

2 Device groups in­ten­ded for use by pro­fes­sion­als and which could harm the health of hu­mans in the case of im­prop­er use are lis­ted in An­nex 6.

3 The groups of devices in An­nex 6 may only be used in ac­cord­ance with the pro­fes­sion­al and op­er­at­ing re­quire­ments stated therein.

Art. 71 Maintenance  

1 Any per­son us­ing devices in a pro­fes­sion­al ca­pa­city must en­sure that the devices are main­tained and tested in ac­cord­ance with the reg­u­la­tions.

2 Main­ten­ance must be car­ried out in ac­cord­ance with the prin­ciples of a qual­ity man­age­ment sys­tem, is to be or­gan­ised ap­pro­pri­ately, and must be guided in par­tic­u­lar by:

a.
the man­u­fac­turer's in­struc­tions;
b.
the par­tic­u­lar risk as­so­ci­ated with the device and its use.

3 For devices with a meas­ure­ment func­tion, test pro­ced­ures may be re­quired in ac­cord­ance with the Meas­ur­ing In­stru­ments Or­din­ance of 15 Feb­ru­ary 200681.

4 Swiss­med­ic can is­sue and pub­lish re­quire­ments for main­ten­ance meas­ures. These re­quire­ments will be deemed to con­sti­tute the cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards.

Art. 72 Reprocessing  

1 Any per­son us­ing in a pro­fes­sion­al ca­pa­city a device in­ten­ded for re­peated use must en­sure on each oc­ca­sion and pri­or to use that its func­tion­al­ity has been tested and that it has been pro­cessed in ac­cord­ance with cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards and tak­ing ac­count of the in­struc­tions of the man­u­fac­turer and the re­quire­ments of hy­giene.

2 Re­pro­cessing must em­ploy suit­able pro­ced­ures that have been val­id­ated in ac­cord­ance with cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards and whose ef­fic­acy has been demon­strated and can be re­li­ably traced and re­pro­duced with­in a qual­ity man­age­ment sys­tem.

3 Any nat­ur­al or leg­al per­son who pro­cesses devices for third parties must:

a.
de­clare that the pro­cessed device:
1.
has been pro­cessed in ac­cord­ance with the man­u­fac­turer's in­struc­tions, or
2.
has been pro­cessed us­ing a pro­ced­ure spe­cif­ic to the pro­cessor that is equally safe and ef­fect­ive as the pro­ced­ure spe­cified by the man­u­fac­turer and has been demon­strated to be equally safe and ef­fect­ive by means of a risk ana­lys­is and val­id­a­tion pro­cess;
b.
op­er­ate a qual­ity man­age­ment sys­tem that is both suit­able and cer­ti­fied to na­tion­ally or in­ter­na­tion­ally re­cog­nised stand­ards;
c.
provide proof that re­pro­cessing takes place in suit­able premises, in ac­cord­ance with the re­cog­nised rules of sci­ence and tech­no­logy and in com­pli­ance with hy­giene re­quire­ments.
d.
doc­u­ment that the device has been pro­cessed in ac­cord­ance with let­ter a.

4 The de­clar­a­tion re­quired un­der para­graph 3 let­ter a must identi­fy the device and state the name and ad­dress of the es­tab­lish­ment that pro­cessed it.

Art. 73 Single-use devices and their reprocessing  

1 Re­pro­cessing and fur­ther use of single-use devices is for­bid­den.

2 Single-use devices re­pro­cessed in a for­eign coun­try un­der Art­icle 17 para­graph 3 EU-MDR82 must neither be used nor made avail­able on the mar­ket.

82 See the foot­note to Art. 4 para. 1 let. f.

Art. 74 Cyber security  

1 Health­care in­sti­tu­tions must put in place all tech­nic­al and or­gan­isa­tion­al re­sources re­quired by the state of the art to en­sure that net­work-com­pat­ible products are pro­tec­ted against elec­tron­ic at­tack and un­au­thor­ised ac­cess.

2 Hos­pit­als must identi­fy, eval­u­ate and doc­u­ment the meas­ures taken un­der para­graph 1 in ac­cord­ance with the prin­ciples of a risk man­age­ment sys­tem. This sys­tem forms an in­teg­ral part of the hos­pit­als’ qual­ity man­age­ment sys­tem.

Chapter 9 Market Surveillance

Art. 75 Principle  

1 In­spec­tions un­der the aus­pices of mar­ket sur­veil­lance will cov­er devices made avail­able on the mar­ket, con­form­ity as­sess­ment pro­ced­ures, device sur­veil­lance, device hand­ling and eco­nom­ic op­er­at­ors’ ful­fil­ment of their ob­lig­a­tions. They will also cov­er devices made avail­able in con­tract­ing states by nat­ur­al or leg­al per­sons dom­i­ciled in Switzer­land, the con­form­ity as­sess­ment pro­ced­ures and sur­veil­lance activ­it­ies for such devices and the nat­ur­al or leg­al per­sons’ ful­fil­ment of their ob­lig­a­tions.

2 The mar­ket sur­veil­lance activ­it­ies un­der­taken by Swiss­med­ic and the Can­tons are gov­erned by Art­icles 93–95, 97 and 98 EU-MDR83. Art­icles 97 para­graph 3 and 98 para­graphs 3 and 4 EU-MDR are ex­cluded.

3 The Can­tons will draw up an­nu­al plans for their mar­ket sur­veil­lance activ­it­ies un­der para­graph 2. They will provide Swiss­med­ic with an an­nu­al sum­mary of the res­ults of their sur­veil­lance activ­it­ies. Swiss­med­ic can de­term­ine both the con­tent of the sum­mary and the form in which it is made avail­able.

4 In case of an ac­tu­al ne­ces­sity for the pro­tec­tion of pub­lic health, Swiss­med­ic will de­cree the meas­ures un­der Art­icle 66 TPA in a gen­er­al rul­ing.

83 See the foot­note to Art. 4 para. 1 let. f.

Art. 76 Responsibilities  

1 Swiss­med­ic is re­spons­ible for mon­it­or­ing:

a.
devices and device con­form­ity;
b.
vi­gil­ance;
c.
main­ten­ance and re­pro­cessing of devices:
1.
in hos­pit­als,
2.
that are in­ten­ded for use in hos­pit­als.

2 Cer­tain as­pects of the mon­it­or­ing activ­it­ies set out in para­graph 1 re­main the re­spons­ib­il­ity of oth­er fed­er­al of­fices or in­sti­tu­tions.

3 The Can­tons are re­spons­ible for mon­it­or­ing:

a.
the re­tail trade and dis­pens­ing points;
b.
the manu­al pro­duc­tion of cus­tom-made devices, of sys­tems and of pro­ced­ure packs;
c.
main­ten­ance and re­pro­cessing of devices by the pro­fes­sion­als us­ing them and in health­care in­sti­tu­tions with the ex­cep­tion of hos­pit­als.
Art. 77 Powers  

1 For the pur­poses of veri­fy­ing con­form­ity, the au­thor­it­ies re­spons­ible for mon­it­or­ing un­der Art­icle 76 may, without provid­ing com­pens­a­tion:

a.
de­mand the proof and in­form­a­tion re­quired;
b.
take samples;
c.
have the samples tested or sub­mit­ted to labor­at­ory ex­am­in­a­tion;
d.
enter and in­spect, dur­ing nor­mal work­ing hours and with ad­vance no­tice or, if ne­ces­sary, un­an­nounced, the busi­ness premises and fa­cil­it­ies of nat­ur­al or leg­al per­sons who have an ob­lig­a­tion to provide in­form­a­tion;
e.
con­sult doc­u­ments and de­mand that they, or ad­di­tion­al in­form­a­tion, be provided in one of the of­fi­cial lan­guages of Switzer­land or in Eng­lish.

2 If a man­u­fac­turer or a nat­ur­al or leg­al per­son who as­sembles sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR84 fails to ful­fil their ob­lig­a­tions un­der Art­icle 66, Swiss­med­ic may im­pose ap­pro­pri­ate meas­ures to pro­tect health, up to and in­clud­ing pro­hib­it­ing the mak­ing avail­able on the mar­ket or the put­ting in­to ser­vice of the devices in ques­tion.85

84 See the foot­note to Art. 4 para. 1 let. f.

85 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

Art. 78 Duty to cooperate and provide information  

Eco­nom­ic op­er­at­ors that place a device on the mar­ket in Switzer­land or in a con­tract­ing state, and eco­nom­ic op­er­at­ors, pro­fes­sion­als and health­care in­sti­tu­tions that make a device avail­able or put it in­to ser­vice in Switzer­land or a con­tract­ing state have a duty to co­oper­ate on mat­ters of en­force­ment. In par­tic­u­lar, they must provide, free of charge, all ne­ces­sary in­form­a­tion and all ne­ces­sary proof and doc­u­ment­a­tion to the en­force­ment bod­ies.

Chapter 10 Data Processing

Section 1 Data Processing in general

Art. 79 Processing of personal data  

Swiss­med­ic and third parties con­trac­ted by Swiss­med­ic are em­powered to pro­cess the per­son­al data that they need to per­form the tasks man­dated to them by this Or­din­ance. Spe­cific­ally, this in­cludes:

a.
health data ac­quired in the course of mar­ket sur­veil­lance and vi­gil­ance;
b.
data doc­u­ment­ing the re­li­ab­il­ity and pro­fes­sion­al qual­i­fic­a­tions of vi­gil­ance con­tact per­sons (Art. 67 para. 2) or the in­di­vidu­als re­spons­ible for com­pli­ance with the reg­u­la­tions (Art. 49 and 52).
Art. 80 Operation of information systems  

1 It is Swiss­med­ic’s re­spons­ib­il­ity to en­sure that its in­form­a­tion sys­tems op­er­ate se­curely and that data is pro­cessed in ac­cord­ance with leg­al re­quire­ments.

2 It will draw up a set of pro­cessing rules for each in­form­a­tion sys­tem. These will spe­cify the tech­nic­al and or­gan­isa­tion­al meas­ures to be taken to en­sure that the data is pro­tec­ted and se­cure.

Art. 81 Access rights  

1 The fol­low­ing per­sons and agen­cies will be giv­en on­line ac­cess to in­form­a­tion sys­tems provided this is ne­ces­sary for the ful­fil­ment of their re­spect­ive tasks:

a.
Swiss­med­ic staff em­ployed in vi­gil­ance and mar­ket sur­veil­lance and third parties man­dated to per­form tasks in this area;
b.
Swiss­med­ic staff em­ployed in ad­min­is­trat­ive pen­al law;
c.
Swiss­med­ic ad­min­is­trat­ors and man­dated third parties.

2 A log of per­sons and bod­ies gran­ted ac­cess to the in­form­a­tion sys­tems will be kept. The data in this log will be stored for two years.

Art. 82 Data archiving and deletion  

Per­son­al data will be stored for a peri­od of ten years from the fi­nal entry. On the ex­piry of this peri­od, it will be des­troyed.

Section 2 Medical Devices Information System

Art. 83 Responsible authority  

Swiss­med­ic is re­spons­ible for the med­ic­al devices in­form­a­tion sys­tem re­quired un­der Art­icle 62c TPA (med­ic­al devices in­form­a­tion sys­tem).

Art. 84 Data protection and security  

1 Swiss­med­ic shall draw up pro­cessing rules in ac­cord­ance with Art­icle 21 of the Or­din­ance of 14 June 199386 to the Fed­er­al Act on Data Pro­tec­tion (OFADP).

2 Art­icles 20 and 21 OFADP ap­ply to data se­cur­ity.

3 Data pro­cessing must be auto­mat­ic­ally logged.

Art. 85 Content of the medical devices information system  

1 This med­ic­al devices in­form­a­tion sys­tem con­tains the fol­low­ing data:

a.
device data;
b.
data on eco­nom­ic op­er­at­ors;
c.
data on the des­ig­nated bod­ies and cer­ti­fic­ates is­sued by them;
d.
data on clin­ic­al tri­als;
e.
vi­gil­ance data;
f.
mar­ket sur­veil­lance data;
g.
data that can be used to man­age and ad­apt the med­ic­al devices in­form­a­tion sys­tem (sys­tem data);
h.
au­then­tic­a­tion data, as­signed user roles and ba­sic set­tings for us­ing the med­ic­al devices in­form­a­tion sys­tem (user data).

2 The med­ic­al devices in­form­a­tion sys­tem only con­tains per­son­al data where such data is re­quired to re­cord and pro­cess in­form­a­tion.

Art. 86 Data exchange with other information systems  

The med­ic­al devices in­form­a­tion sys­tem can draw the data spe­cified in Art­icle 85 from Eu­damed and from can­ton­al elec­tron­ic sys­tems; it can also sub­mit data to Eu­damed and can­ton­al sys­tems.

Art. 87 Access rights  

Swiss­med­ic has ac­cess to all data re­cor­ded in and pro­cessed by the med­ic­al devices in­form­a­tion sys­tem.

Art. 88 Data subjects’ rights and data rectification  

1 Data sub­jects’ rights, par­tic­u­larly the right to in­form­a­tion, rec­ti­fic­a­tion and de­le­tion of data, are gov­erned by data pro­tec­tion le­gis­la­tion.

2 Swiss­med­ic will en­sure that data that is in­cor­rect or has been pro­cessed un­law­fully is cor­rec­ted in or de­leted from the med­ic­al devices in­form­a­tion sys­tem. Cor­rec­tion and de­le­tion will take place as quickly as pos­sible, but no later than 60 days of the data sub­ject mak­ing their re­quest.

Art. 89 Data archiving  

The per­son­al data spe­cified in Art­icle 85 para­graph 2 must be stored in such a way that it is only pos­sible to identi­fy data sub­jects for a peri­od of ten years after the last device covered by the de­clar­a­tion of con­form­ity was placed on the mar­ket. For im­plant­able devices, this peri­od is ex­ten­ded to 15 years.

Art. 90 Publication of data  

Swiss­med­ic may pub­lish the fol­low­ing in the med­ic­al devices in­form­a­tion sys­tem:

a.
product data, as spe­cified in ac­cord­ance Part B of An­nex VI to EU-MDR87;
b.
in­form­a­tion on eco­nom­ic op­er­at­ors and devices, as spe­cified in Part A of An­nex VI to EU-MDR;
c.
the gen­er­al in­form­a­tion spe­cified in Art­icle 35 para­graph 7 EU-MDR gov­ern­ing the as­sess­ment, des­ig­na­tion and no­ti­fic­a­tion of con­form­ity as­sess­ment bod­ies and for the mon­it­or­ing of des­ig­nated bod­ies, and on changes that have a sig­ni­fic­ant im­pact on such tasks;
d.
sum­mar­ies of the an­nu­al re­port on mon­it­or­ing and on-site as­sess­ment activ­it­ies drawn up in ac­cord­ance with Art­icle 44 para­graph 12 EU-MDR;
e.
sum­mar­ies of safety and clin­ic­al per­form­ance in ac­cord­ance with Art­icle 63;
f.
in­form­a­tion on cer­ti­fic­ates is­sued un­der Art­icles 28 and 42–44;
g.
field safety no­tices for users or cus­tom­ers is­sued in the course of field safety cor­rect­ive ac­tions in ac­cord­ance with Art­icle 89 para­graph 8 EU-MDR;
h.
sum­mar­ies of the re­ports on Swiss­med­ic's activ­it­ies in mon­it­or­ing mar­ket sur­veil­lance;
i.
sci­entif­ic opin­ions in ac­cord­ance with Art­icle 106 para­graph 12 EU-MDR;
j.
in­form­a­tion on mar­ket mon­it­or­ing activ­it­ies, par­tic­u­larly re­calls, on non-con­form­ing devices and pre­vent­ive health pro­tec­tion meas­ures.

87 See the foot­note to Art. 4 para. 1 let. f.

Art. 91 Subsequent use of data  

Non-per­son­al data can be used for the in­de­pend­ent as­sess­ment of long-term device safety or per­form­ance or of the trace­ab­il­ity of im­plant­able products.

Art. 92 Applicability of the Data Protection Act  

All data pro­cessing activ­it­ies car­ried out in the med­ic­al devices in­form­a­tion sys­tem must com­ply with the Fed­er­al Act of 19 June 199288 on Data Pro­tec­tion.

Chapter 11 Final Provisions

Section 1 Enforcement

Art. 93 Amendment of Annexes  

1 The FDHA can amend An­nexes 1–3 to this Or­din­ance in line with in­ter­na­tion­al and tech­nic­al pro­gress.

2 Where amend­ments may pose tech­nic­al bar­ri­ers to trade, it will ef­fect them by mu­tu­al agree­ment with the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search.

Art. 94 Information on directly applicable legal acts of the European Commission  

Swiss­med­ic will provide on its web­site in­form­a­tion on leg­al acts of the European Com­mis­sion that, ac­cord­ing to this Or­din­ance, are dir­ectly ap­plic­able in Switzer­land in the ver­sion bind­ing upon the Mem­ber States of the EU and as lis­ted in An­nex 4.

Art. 95 Harmonisation of enforcement  

1 When im­ple­ment­ing this Or­din­ance, Swiss­med­ic will re­spect the im­ple­ment­ing acts ad­op­ted by the European Com­mis­sion on the basis of EU-MDR89.

2 Reg­u­la­tions (EU) No 207/201290 and No 722/201291 will re­main in force un­til such time as they are re­pealed in the EU by im­ple­ment­ing acts ad­op­ted by the European Com­mis­sion on the basis of EU-MDR.

89 See the foot­note to Art. 4 para. 1 let. f.

90 Com­mis­sion Reg­u­la­tion (EU) No 207/2012 of 9 March 2012 on elec­tron­ic in­struc­tions for use of med­ic­al devices, ver­sion ac­cord­ing to OJ L 72 of 10.3.2012, p. 28.

91 Com­mis­sion Reg­u­la­tion (EU) No 722/2012 of 8 Au­gust 2012 con­cern­ing par­tic­u­lar re­quire­ments as re­gards the re­quire­ments laid down in Coun­cil Dir­ect­ives 90/385/EEC and 93/42/EEC with re­spect to act­ive im­plant­able med­ic­al devices and med­ic­al devices man­u­fac­tured util­ising tis­sues of an­im­al ori­gin, ver­sion ac­cord­ing to OJ L 212 of 9.8.2012, p. 3.

Art. 96 Cooperation with the European Commission and authorities of the contracting states  

1 Where provided for by in­ter­na­tion­al agree­ments, Swiss­med­ic, the des­ig­nated bod­ies and eco­nom­ic op­er­at­ors will co­oper­ate with the European Com­mis­sion and the au­thor­it­ies of the con­tract­ing states.

2 Swiss­med­ic can ap­point ex­perts who are qual­i­fied to eval­u­ate con­form­ity as­sess­ment bod­ies in the field of med­ic­al devices.

3 The Agency may ap­point ex­pertsto par­ti­cip­ate in ex­pert groups of the European Com­mis­sion and the au­thor­it­ies of the con­tract­ing states.

Art. 97 Collaboration with the customs authorities  

1 The cus­toms au­thor­it­ies provide Swiss­med­ic with in­form­a­tion on the im­port, ex­port and trans­it of devices.

2 Swiss­med­ic can man­date the cus­toms au­thor­it­ies to de­tain devices for fur­ther in­spec­tion and to ob­tain samples.

Art. 98 Expert laboratories in Switzerland  

1 Labor­at­or­ies that wish to be des­ig­nated an ex­pert labor­at­ory by the European Com­mis­sion in ac­cord­ance with Art­icle 106 para­graph 7 EU-MDR92 may ap­ply to Swiss­med­ic for des­ig­na­tion.

2 They must demon­strate to Swiss­med­ic in par­tic­u­lar that they:

a.
meet the cri­ter­ia set out in Art­icle 106 para­graph 8 EU-MDR; and
b.
are able to as­sume the tasks un­der Art­icle 106 para­graph 10 EU-MDR, tak­ing ac­count of the amend­ments to this pro­vi­sion ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts93, in ac­cord­ance with the re­quire­ments in each case.

3 They must op­er­ate in one of the fol­low­ing fields:

a.
physico-chem­ic­al char­ac­ter­isa­tion;
b.
mi­cro­bi­o­lo­gic­al, mech­an­ic­al, elec­tric­al, elec­tron­ic or non-clin­ic­al bio­lo­gic­al and tox­ic­o­lo­gic­al test­ing or biocom­pat­ib­il­ity test­ing.

4 If the re­quire­ments are met, Swiss­med­ic will pro­pose to the EU Com­mis­sion that the labor­at­ory be des­ig­nated an ex­pert labor­at­ory.

92 See the foot­note to Art. 4 para. 1 let. f.

93 See An­nex 4.

Section 2 Repeal of other Legislation and Transitional Provisions

Art. 99 Repeal of other legislation  

The fol­low­ing or­din­ances are re­pealed:

1.
the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 200194;
2.
Or­din­ance of 22 June 200695 on the List of Pre­scrip­tion Med­ic­al Devices.

94 [AS 2001 3487;20044037no I 5, II para. 2; 20084377An­nex 5 no 2; 20101215, 2749no I 7; 2015 999; 2017 5935; 2019 999Art. 28 para. 2; 2020 2975]

95 [AS 2006 3679]

Art. 100 Validity of certificates issued under the old legislation  

1 Cer­ti­fic­ates is­sued un­der the old le­gis­la­tion pri­or to 25 May 2017 will re­tain their valid­ity un­til the ex­piry date stated therein, but no longer than 26 May 2022.

2 Cer­ti­fic­ates is­sued un­der the old le­gis­la­tionsince 25 May 2017 will re­tain their valid­ity un­til the ex­piry date stip­u­lated in them, but no longer than 26 May 2024.

Art. 101 Placing on the market of products that comply with the old legislation  

1 Provided they con­tin­ue to com­ply with the old le­gis­la­tion from 26 May 2021 and have not un­der­gone any sig­ni­fic­ant changes in their design or in­ten­ded pur­pose, the fol­low­ing med­ic­al devices may be placed on the mar­ket or put in­to ser­vice un­til 26 May 2024:

a.
devices clas­si­fied as class I un­der the old le­gis­la­tion for which a de­clar­a­tion of con­form­ity was is­sued be­fore 26 May 2021 and for which the con­form­ity as­sess­ment pro­ced­ure un­der this Or­din­ance ne­ces­sit­ates the in­volve­ment of a des­ig­nated body;
b.
devices with a cer­ti­fic­ate val­id un­der Art­icle 100.

2 The post-mar­ket sur­veil­lance and mar­ket mon­it­or­ing of these devices, vi­gil­ance, and re­gis­tra­tion of eco­nom­ic op­er­at­ors and of the devices them­selves are sub­ject to the pro­vi­sions of this Or­din­ance.

3 Devices leg­ally placed on the mar­ket pri­or to 26 May 2021 un­der the old le­gis­la­tion and devices placed on the mar­ket from 26 May 2021 un­der para­graph 1 can con­tin­ue to be placed on the mar­ket or put in­to ser­vice un­til 26 May 2025. The above is sub­ject to Art­icle 103.

Art. 102 Exemptions for non-compliant medical devices  

Ex­emp­tions is­sued by Swiss­med­ic un­der Art­icle 9 para­graph 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 200196 shall re­tain their valid­ity.

96 See the foot­note to Art. 99 no 1.

Art. 103 Devices incorporating devitalised tissue or cells of human origin  

1 Devices in­cor­por­at­ing de­vi­tal­ised tis­sue or cells of hu­man ori­gin or their de­riv­at­ives as spe­cified in Art­icle 1 para­graph 3 let­ter c no. 2 and d that were law­fully placed on the mar­ket or put in­to ser­vice pri­or to 26 May 2021 may still be placed on the mar­ket or put in­to ser­vice un­til 26 May 2025. Art. 101 para­graph 2 ap­plies mu­tatis mutandis.

2 Un­til such time as a cor­res­pond­ing spe­cial Or­din­ance is is­sued, devices covered by Art­icle 2a para­graph 2 TPA are sub­ject to the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 200197. Devices covered by Art­icle 2a para­graph 2 TPA that were law­fully placed on the mar­ket pri­or to 26 May 2021 may still be placed on the mar­ket or put in­to ser­vice un­til such time as a cor­res­pond­ing spe­cial Or­din­ance is is­sued.

97 See the foot­note to Art. 99 no 1.

Art. 104 Affixing the UDI  

The UDI re­quired by Art­icle 17 para­graph 2 must be af­fixed:

a.
for im­plant­able and class III devices: from 26 May 2021;
b.
for class IIa and IIb devices: from 26 May 2023;
c.
for class I devices: from 26 May 2025;
d.
for re­usable devices where the UDI has to be af­fixed to the product it­self: two years after the dates giv­en in let­ters a–c for the rel­ev­ant product class.
Art. 104a Appointment of authorised representatives 98  

1 If the man­u­fac­turer is dom­i­ciled in an EU or EEA state, or if the man­u­fac­turer has des­ig­nated an au­thor­ised rep­res­ent­at­ive dom­i­ciled in an EU or EEA state, that man­u­fac­turer must des­ig­nate an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51 para­graph 1 with­in the fol­low­ing time peri­ods:

a.
for class III devices, class IIb im­plant­able devices and act­ive im­plant­able devices: by 31 Decem­ber 2021;
b.
for non-im­plant­able class IIb devices and class IIa devices: by 31 March 2022;
c.
for class I devices: by 31 Ju­ly 2022.

2 For sys­tems and pro­ced­ure packs, an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51 para­graph 5 must be ap­poin­ted by 31 Ju­ly 2022.

98 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

Art. 104b Registration by economic operators 99  

Eco­nom­ic op­er­at­ors that have placed devices on the mar­ket pri­or to 26 May 2021 in ac­cord­ance with Art­icle 22a of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001100 must re­gister the in­form­a­tion re­quired un­der Art­icle 55 para­graphs 1 and 5 by 26 Novem­ber 2021.

99 In­ser­ted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)

100 See the foot­note to Art. 99 no 1.

Art. 105 In vitro diagnostic medical devices 101  

1 Un­til such time as a cor­res­pond­ing spe­cial Or­din­ance is is­sued, in vitro dia­gnost­ic med­ic­al devices are sub­ject to the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001102, sub­ject to para­graphs 2 and 3.

2 In vitro dia­gnost­ic med­ic­al devices must not carry the name and ad­dress of the nat­ur­al or leg­al per­son who first places them on the Swiss mar­ket on their la­belling, out­er pack­aging or in­struc­tions for use if they carry the name and ad­dress of the nat­ur­al or leg­al per­son who places them on the mar­ket in an EU or EEA state.

3 In vitro dia­gnost­ic med­ic­al devices that have been no­ti­fied to the com­pet­ent au­thor­ity of an EU or EEA state in ac­cord­ance with Art­icle 6 para­graph 2 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001 do not have to be ad­di­tion­ally no­ti­fied to Swiss­med­ic.

101 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

102 See the foot­note to Art. 99 no 1.

Art. 106 Devices without an intended medical purpose  

Un­less Swiss­med­ic has des­ig­nated com­mon spe­cific­a­tions in ac­cord­ance with Art­icle 8 para­graph 1 for devices without an in­ten­ded med­ic­al pur­pose in ac­cord­ance with An­nex 1, these devices are sub­ject to the old le­gis­la­tion.

Art. 107 Conformity assessment bodies  

1 Con­form­ity as­sess­ment body des­ig­na­tions is­sued un­der Sec­tion 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001103 will be­come void.

2 The con­form­ity as­sess­ment body that is­sued the cer­ti­fic­ates un­der the old le­gis­la­tion will re­main re­spons­ible for ad­equately mon­it­or­ing these devices. It will be sub­ject to su­per­vi­sion by Swiss­med­ic.

3 Con­form­ity as­sess­ment body des­ig­na­tions is­sued un­der Sec­tion 4a of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001 will re­tain their valid­ity.

4 Un­til a spe­cial Or­din­ance for in vitro dia­gnost­ic med­ic­al devices enters in­to force, the con­form­ity as­sess­ment bod­ies for these devices will con­tin­ue to be des­ig­nated in ac­cord­ance with Sec­tion 4 and 4a of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001.

103 See the foot­note to Art. 99 no 1.

Art. 108 Reporting devices, systems and procedure packs 104  

1 Un­til Art­icle 17 para­graph 5 comes in­to force, the fol­low­ing re­port­ing ob­lig­a­tions will con­tin­ue to ap­ply to nat­ur­al or leg­al per­sons dom­i­ciled in Switzer­land:

a.
for man­u­fac­tur­ers and nat­ur­al or leg­al per­sons who as­semble sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR105: the re­port­ing ob­lig­a­tions set out in Art­icle 6 para­graphs 1 and 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001106:
b.
for nat­ur­al or leg­al per­sons who place med­ic­al devices on the mar­ket un­der Art­icle 2 para­graph 1 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001: the re­port­ing ob­lig­a­tions set out in Art­icle 6 para­graphs 3 and 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001.

2 ...107

104 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

105 See the foot­note to Art. 4 para. 1 let. f.

106 See the foot­note to Art. 99 no 1.

107 To enter in­to force in due course (Art. 110 para. 2).

Art. 109108  

108 Re­pealed by No I of the O of 19 May 2021, with ef­fect from 26 May 2021 (AS 2021 281).

Art. 110 Commencement  

1 Sub­ject to the ex­cep­tions in para­graph 2, this Or­din­ance comes in­to force on 26 May 2021.

2 Art­icles 17 para­graph 5 and 108 para­graph 2 will come in­to force at a later date.109

109 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Annex 1

(Art. 1 para. 1 letter b)

Product groups without an intended medical purpose

1. Contact lenses or other items intended to be introduced into or onto the eye.

2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of products used in tattooing or body piercing.

3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.

4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

6. Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

Annex 2

(Art. 5 para. 1)

Equivalent terms

The terms listed below and used in EU-MDR110 and this Ordinance are equivalent as follows:

EU

Switzerland

a. English terms

Union

Switzerland

Member State

Switzerland

Third country

Other state

Union market

Swiss market

Union legislation /
Union harmonisation legislation

Legislation

Harmonised standard

Designated standard

State of the art

Scientific and technological standards

EU declaration of conformity

Declaration of conformity

Official Journal of the European Union

Federal Gazette (Bundesblatt)

Established outside / within the Union

Domiciled in / outside Switzerland

Authority

Competent authority under Swiss law

Healthcare professional

Professional

Suspension

Suspension

Withdrawal

Revocation

Transplants

Organs

b. German terms

Union

Schweiz

Mitgliedstaat

Schweiz

Drittstaat / Drittland

anderer Staat

Unionsmarkt

Schweizer Markt

Rechtsvorschriften der Union /
Harmonisierungsrechtssvorschriften der Union

Rechtsvorschriften

Harmonisierte Norm

Bezeichnete Norm

Stand der Technik

Stand von Wissenschaft und Technik

EU-Konformitätserklärung

Konformitätserklärung

Amtsblatt der Europäischen Union

Bundesblatt

Ausserhalb / In der Union ansässig

Sitz ausserhalb / in der Schweiz

Behörde

Nach schweizerischem Recht zuständige Behörde

Angehörige der Gesundheitsberufe

Fachpersonen

Aussetzung

Suspendierung

Zurückziehung

Widerruf

Transplantate

Organe

Union

Suisse

c. French terms

État membre

Suisse

État tiers / pays tiers

autre État

marché de l’Union

marché suisse

législation (actes législatifs) de l’Union /
législation d’harmonisation de l’Union

législations

norme harmonisée

norme désignée

état de l’art

état de la science et de la technique

déclaration de conformité UE

déclaration de conformité

investigation clinique

essai clinique

dispositif faisant l’objet d’une investigation

dispositif faisant l’objet d’un essai clinique

Journal officiel de l’Union européenne

Feuille fédérale

situé hors de l’Union / établi dans l’Union

sis à l’étranger / en Suisse

notice d’utilisation

mode d’emploi

conditionnement

emballage

notification des incidents graves

déclaration des incidents graves

autorités

autorités compétentes en vertu du droit suisse

professionnels de la santé

professionnels

retrait

révocation

d. Italian terms

Unione

Svizzera

Stato Membro

Svizzera

paese terzo

altro Stato

mercato dell’Unione

mercato svizzero

legislativo dell’Unione /
normativa di armonizzazione dell’Unione

legislazioni

norma armonizzata

norma designata

stato dell’arte

stato della scienza e della tecnica

dichiarazione di conformità UE

dichiarazione di conformità

marcatura CE di conformità

marchio di conformità

Gazzetta ufficiale dell’Unione europea

Foglio federale

avente sede fuori dall’Unione,/ stabilito nell’Unione

avente sede all’estero/ in Svizzera

autorità

autorità competente secondo il diritto svizzero

operatori sanitari

specialisti

controllata

società controllata

ritiro

revoca

immissione sul mercato

immissione in commercio

segnalazione di incidenti gravi

notifica di incidenti gravi

indagini cliniche

sperimentazioni cliniche

dispositivo oggetto di indagine

dispositivo oggetto di sperimentazione clinica

confezionamento

imballaggio

110 See the footnote to Art. 4 para. 1 let. f.

Annex 3

(Art. 5 para. 2)

Applicable law

1 EU law

Where this Ordinance makes reference to provisions of EU-MDR111 that in turn make reference to EU law, the versions below are applicable:

1.1 Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, (OJ L 353 of 31.12.2080, p. 1).

1.2 Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72 of 10.3.2012, p. 28).

1.3 Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin(OJ L 212 of 9.8.2012, p. 3).

111 See the footnote to Art. 4 para. 1 let. f.

2 Swiss law

Where this Ordinance makes reference to provisions of EU-MDR112 that in turn make reference to EU law, the Swiss law below is applicable in place of the EU law:

EU law

Swiss legislation

1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311 of 28.1.2001, p. 67.

Therapeutic Products Act
of 15 December 2000113

2. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136 of 30.4.2004, p. 1.

Therapeutic Products Act
of 15 December 2000

3. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, OJ L 324 of 10.12.2017, p. 121.

Therapeutic Products Act
of 15 December 2000

4. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, OJ L 117 of 5.5.2017, p. 176.

Therapeutic Products Act
of 15 December 2000

5. Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210 of 7.8.1985, p. 29.

Product Liability Act
of 18 June 1993114

6. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility, OJ L 96 of 29.3.2001, p. 79.

Ordinance of
25 November 2015115
on Electromagnetic
Compatibility

7. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC, OJ L 157 of 09.06.2006, p. 24.

Machine Ordinance
of 2 April 2008116

8. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ L 324 of 22.12.2009, p. 59.

FDHA Ordinance
of 16 December 2016117
on Cosmetics

9. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 102 of 7.4.2004, p. 48.

Therapeutic Products Act
of 15 December 2000
and Transplantation Act
of 8 October 2004118

10. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, OJ L 33 of 8.2.2003, p. 30.

Therapeutic Products Act of
15 December 2000 and
Transplantation Act
of 8 October 2004

11. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
OJ L 31 of 1.2.2002, p. 1.

Foodstuffs Act
of 20 June 2014119

12. Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council, OJ L 316 of 14.11.2021, p. 12.

Therapeutic Products Act of
15 December 2000 and
Federal Act of 6 October 1995120
on Technical Barriers to Trade

13. Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000
on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, OJ L 8 of 12.1.2001, p. 1.

Federal Act of 19 June 1992121
on Data Protection

14. Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218 of 13.8.2008, p. 30.

Federal Act of 6 October 1995
on Technical Barriers to Trade
and Product Safety Act
of 12 June 2009122

15. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1.

Chemicals Act of
15 December 2000123

16. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ L 167 of 27.6.2012, p. 1.

Ordinance on Biocidal Products
of 18 May 2005124

17. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC, OJ L 39 of 15.2.1980, p. 40.

Metrology Act of 17 June 2011125

18. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom, OJ L 13 of 17.1.2014, p. 1.

Radiological Protection Act
of 22 March 1991126

19. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, OJ L 50 of 20.2.2004, p. 44.

Ordinance of 18 May 2005127
on Good Laboratory Practice

20. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189 of 20.7.1990, p. 17.

Medical Devices Ordinance
of 17 October 2001

21. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12.7.1993, p. 1.

Medical Devices Ordinance
of 17 October 2001

112 See the footnote to Art. 4 para. 1 let. f.

113 SR 812.21

114 SR 221.112.944

115 SR 734.5

116 SR 819.14

117 SR 817.023.31

118 SR 810.21

119 SR 817.0

120 SR 946.51

121 SR 235.1

122 SR 930.11

123 SR 813.1

124 SR 813.12

125 SR 941.20

126 SR 814.50

127 SR 813.112.1

Annex 4 128

128 Revised by rectification of 4 May 2021 (AS 2021 260).

(Art. 4 para. 2, 17 para. 4, 19 para. 1 let. c, 20 para. 1, 23, 25 para. 3, 29 para. 2, 45 para. 2, 46 para. 3, 47 para. 1 and 98 para. 2 let. b)

Delegated acts of the European Commission based on EU-MDR 129

129 See the footnote to Art. 4 para. 1 let. f.

For the purposes of implementing this Ordinance, the legal acts adopted on the basis of the provisions of EU-MDR set out below will apply in Switzerland in the binding version applicable to the EU Member States:

Subject matter

Passed by the European Commission based on the EU-MDR

Art. 4 para. 2 MedDO

Delegated act in accordance with Art. 3 EU-MDR

Art. 17 para. 4 MedDO

Delegated act in accordance with Art. 27 para. 10 EU-MDR

Art. 19, para. 1 let. c MedDO

Implementing act in accordance with Article 42 paragraph 13
EU-MDR

Art. 20 para. 1 MedDO

Delegated act in accordance with Art. 18 para. 3 EU-MDR

Art. 23 MedDO

Delegated act in accordance with Art. 52 para. 5 EU-MDR

Art. 25 para. 3 MedDO

Delegated act in accordance with Art. 56 para. 6 EU-MDR

Art. 29 para. 2 MedDO

Delegated act in accordance with Art. 19 para. 4 EU-MDR

Art. 45 para. 2 MedDO

Delegated act in accordance with Art. 44 para. 11 EU-MDR

Art. 46 para. 3 MedDO

Delegated act in accordance with Art. 61 para. 8 EU-MDR

Art. 47 para. 1 MedDO

Delegated act in accordance with Art. 10 para. 4 EU-MDR

Art. 98 para. 2 letter b MedDO

Delegated act in accordance with Art. 106 para. 15 EU-MDR

Annex 5

(Art. 13 para. 1)

Conformity marking

The conformity marking is as follows:

Where a designated body has to be involved, its identification number is to be placed beside its conformity marking.

Annex 6

(Art. 70, paras 2 and 3)

Product groups intended for use by professionals, qualifications and circumstances of use

1. Product groups

Devices for injection intended to remain in the human body for longer than 30 days (long-term injectable devices) must only be used by a doctor or by a professional with the qualifications set out in number 2 under the direct supervision of a doctor, who will be deemed accountable.

2. Qualifications

Long-term injectable devices may be used by qualified healthcare professionals with appropriate training in the injection of long-term implantable devices.

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