The Euro­pean Com­mis­sion has giv­en in and makes con­ces­sions to the indus­try. On Octo­ber 14, 2021 the Com­mis­sion issued the cor­re­spond­ing pro­pos­al for a par­tial delay of Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). The pro­pos­al still has to be con­firmed by Euro­pean Coun­cil and Par­lia­ment. It is, how­ev­er, broad­ly expect­ed that it will be adopted. 

The back­ground for this par­tial delay was the often-com­plained lack of readi­ness of required infra­struc­ture for the IVDR. A promi­nent and often dis­cussed exam­ple is the low num­ber of noti­fied bod­ies under the IVDR – to date, only six orga­ni­za­tions have been des­ig­nat­ed for the new reg­u­la­tion. Under the IVD Direc­tive (IVDD), 18 noti­fied bod­ies are list­ed. The num­ber of man­u­fac­tur­ers in need for a noti­fied body would increase dra­mat­i­cal­ly under the IVDR because – due to the change of the clas­si­fi­ca­tion sys­tem – an esti­mat­ed 80 to 90% of man­u­fac­tur­ers would be sub­ject to noti­fied body cer­ti­fi­ca­tion where­as this is the case for only 10 to 20% under the IVDD. 

First of all and most impor­tant­ly, the Com­mis­sion does not pro­pose a delay of the IVDR. The reg­u­la­tion will still ful­ly apply as of May 26, 2022

Giv­en the fact that the Euro­pean health insti­tu­tions are and will be strained by the COVID-19 pan­dem­ic, the Com­mis­sion appar­ent­ly did not want to risk essen­tial IVD med­ical devices to dis­ap­pear from the market. 

Key points of the proposal

Now the ques­tion is what exact­ly has been pro­posed? We have briefly sum­ma­rized the most impor­tant points below. 

Key aspects to consider

So what is the mes­sage that can be tak­en from this pro­pos­al? First and fore­most, it is a pro­pos­al. As long as it is not adopt­ed man­u­fac­tur­ers should not ful­ly rely on the pro­posed new dates. Also, the IVDR date of appli­ca­tion would not change. There are still impor­tant aspects to be imple­ment­ed even if the pro­pos­al will be accept­ed. Last, the IVDR remains a reg­u­la­to­ry game chang­er with many chal­lenges ahead. Man­u­fac­tur­ers should not stop or pause their efforts to comply.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website