Euro­pean Com­mis­sion pro­posed MDR dead­lines exten­sion for lega­cy devices

It was obvi­ous that the indus­try and also EU coun­try author­i­ties grew increas­ing­ly alarmed with regards to the approach­ing 26 May 2024 dead­line. It marks the day where man­u­fac­tur­ers of lega­cy devices had to bring their prod­ucts to full com­pli­ance to Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). This was per­ceived as a huge prob­lem due to the lim­it­ed noti­fied body capacity. 

The Com­mis­sion has now giv­en in dur­ing the EPSCO Health Coun­cil meet­ing on Decem­ber 9.  It pro­posed extend­ed stag­gered dead­lines for med­ical devices depend­ing on the device risk class. 

As a result, instead of the cur­rent 2024 com­pli­ance dead­line for all lega­cy prod­ucts, the Com­mis­sion sug­gest­ed the fol­low­ing time­lines and fur­ther items:

• 26 May 2027 for class III and class IIb products;
• 26 May 2028 for class IIa, and I need­ing the involve­ment of a noti­fied body due to changed MDR clas­si­fi­ca­tion rules;
• An exten­sion of the valid­i­ty of the cer­tifi­cates issued under the for­mer Med­ical Devices Direc­tive (MDD) and Active Implantable Med­ical Devices Direc­tive (AIMDD) if need­ed for legal and prac­ti­cal reasons;
• The removal of the sell-off date of 26 May 2025. This last point was also pro­posed for Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR).

Please note that this is a pro­pos­al, which is not yet legal­ly valid. Final pro­vi­sions and more back­ground infor­ma­tion are expect­ed to be avail­able in ear­ly 2023 and we will keep you updat­ed. Also, we would like to reit­er­ate that this will be applic­a­ble only for lega­cy devices.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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