Medical Devices Ordinance
(MedDO)

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 cer­ti­fic­ates 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 shall be is­sued, amended or re-is­sued; and

b.⁷⁹

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 shall re­tain their valid­ity if the man­u­fac­turer of the device 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 mon­it­or­ing func­tions; and

b.

this des­ig­nated body shall be re­spons­ible for the cer­ti­fic­ates dur­ing the peri­od of sus­pen­sion or re­stric­tion.