Medical Devices Ordinance
(MedDO)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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).

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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