Medical Devices Ordinance
(MedDO)

¹ The des­ig­nated body shall provide Swiss­med­ic and the oth­er des­ig­nated bod­ies with:⁶⁵

a.

all in­form­a­tion on cer­ti­fic­ates it has is­sued and any amend­ments or sup­ple­ments to such cer­ti­fic­ates;

b.

in­form­a­tion on sus­pen­ded, re­in­stated or re­voked cer­ti­fic­ates;

c.

in­form­a­tion on cer­ti­fic­ates it has re­fused;

d.

in­form­a­tion on re­stric­tions im­posed on cer­ti­fic­ates.

² It shall also provide Swiss­med­ic with in­form­a­tion on wheth­er or not a con­form­ity as­sess­ment pro­ced­ure should be ap­plied in ac­cord­ance with Art­icle 54 para­graph 1 EU-MDR⁶⁶. 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.⁶⁷