Euro­pean Par­lia­ment ini­tia­tive for MDR improvement

Con­cerns regard­ing avail­abil­i­ty of noti­fied bod­ies have been addressed with delays of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR), but the sit­u­a­tion is not com­plete­ly solved. 

The num­bers of recer­ti­fi­ca­tion and expiry of lega­cy devices around 2027/28 rais­es con­cerns as these may bring new bot­tle­necks. With the assis­tance of spe­cial­ist lawyer Erik Volle­bregt, the Euro­pean Par­lia­ment has launched an ini­tia­tive in late May sug­gest­ing among oth­ers the fol­low­ing key points:

• change the recer­ti­fi­ca­tion time­line for high-risk devices (class III and most class IIb implantables)
• abol­ish recer­ti­fi­ca­tion of low­er risk devices 
• imple­ment­ing prin­ci­ples of good admin­is­tra­tion for noti­fied bodies 
• improv­ing and stream­lin­ing the process of des­ig­na­tion and sur­veil­lance of noti­fied bodies
• cen­tral­i­sa­tion

Sup­port­ing this ini­tia­tive, BVMed pre­sent­ed its posi­tion at the Ger­man Bun­destag to lob­by for a more indus­try friend­ly imple­men­ta­tion of the MDR.

It is hoped that enough pres­sure is put on the Euro­pean Com­mis­sion to achieve a change in reg­u­la­to­ry practice. 

Source: BVMed 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• MDR extend­ed tran­si­tion time­lines and removal of MDR and IVDR sell-off peri­od adopted
• Euro­pean Com­mis­sion pro­pos­al for pro­gres­sive roll-out of the IVDR adopted