Medical Devices Ordinance
(MedDO)

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.