Medical Devices Ordinance
(MedDO)

¹ The re­quire­ments of Art­icles 22 and 29 para­graph 2 EU-MDR ap­ply to the pla­cing on the mar­ket of sys­tems and pro­ced­ure packs²⁹.

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.