Man­u­fac­tur­ers who want to make con­tin­u­ous use of the extend­ed tran­si­tion peri­od under the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) must be able to pro­vide a signed agree­ment for IVDR con­for­mi­ty assessment.

Of those, man­u­fac­tur­ers who have a CE cer­tifi­cate issued by a noti­fied body under the for­mer IVD Direc­tive (IVDD) and who want to change the noti­fied body for IVDR cer­ti­fi­ca­tion, must also be able to pro­vide evi­dence that sur­veil­lance activ­i­ties for the IVDD CE cer­tifi­cate are appro­pri­ate­ly addressed.

For this pur­pose, TEAM-NB has issued a draft agree­ment for the trans­fer of sur­veil­lance responsibilities.

You may access the doc­u­ment here. Please don’t hes­i­tate to get in touch should you have any fur­ther questions.

Source: TEAM-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website