It is now offi­cial­ly con­firmed – Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) will see a pro­gres­sive roll-out as pre­vi­ous­ly pro­posed by the Euro­pean Com­mis­sion. This was con­firmed in a press release from Decem­ber 20, 2021. You may access the release here.

We have sum­ma­rized the result­ing tran­si­tion peri­ods for full com­pli­ance with the IVDR in the table below again:

Risk ClassDead­line
Class D26 May 2025
Class C26 May 2026
Class B26 May 2027
Class A devices placed on the mar­ket in a ster­ile condition26 May 2027

Please note that only those devices that will see a clas­si­fi­ca­tion change due to new IVDR clas­si­fi­ca­tion rules may make use of the extend­ed tran­si­tion peri­ods (bitte als Pul­lquote). Also, devices that have valid noti­fied body cer­tifi­cates under the IVDD may con­tin­ue to be placed on the mar­ket under the IVDD beyond May 26, 2022 as well as in-house devices under cer­tain conditions. 

Devices that will remain in the low­est risk class A must still ful­ly con­form to the IVDR by May 26, 2022.

Please note also that the adop­tion of the pro­pos­al is not a delay of the IVDR. The reg­u­la­tion will still become the over­all reg­u­la­to­ry frame­work for IVD med­ical devices. More­over, to make use of the extend­ed tran­si­tion peri­od, man­u­fac­tur­ers must not imple­ment any sig­nif­i­cant changes to the design or intend­ed pur­pose of the prod­uct and they will have to com­ply to the IVDR require­ments on PMS, vig­i­lance and eco­nom­ic operator/ device registrations.

Should you have any ques­tions or con­cerns, please do not hes­i­tate to get in touch.

Source: Euro­pean Com­mis­sion, Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website