Medical Devices Ordinance
(MedDO)

¹ The des­ig­nated bod­ies is­sue cer­ti­fic­ates of con­form­ity in ac­cord­ance with An­nexes IX–XI to EU-MDR⁶⁴ (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 acts⁶⁵.

⁴ Cer­ti­fic­ates is­sued by bod­ies des­ig­nated un­der EU law and dom­i­ciled in a state of the EU or European Eco­nom­ic Area (EEA) 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 ap­plied meet Swiss re­quire­ments; and

b.

the cer­ti­fic­ates were is­sued by a body with an equi­val­ent qual­i­fic­a­tion to that re­quired in Switzer­land.⁶⁶