Extend­ed IVDR tran­si­tion peri­od for cer­tain IVD med­ical devices

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. 

• 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 and thus become the gen­er­al legal frame­work for IVD med­ical devices. 
• Depend­ing on the IVDR risk class that would apply under the IVDR, extend­ed tran­si­tion peri­ods may apply for devices that did not require noti­fied body involve­ment under the IVDD and for which the dec­la­ra­tion of con­for­mi­ty was drawn up before May 26, 2022:
  • Class A ster­ile and class B devices may con­tin­ue to be placed on the mar­ket or put into ser­vice under the IVDD until May 26, 2027.
  • Class C devices may con­tin­ue to be placed on the mar­ket or put into ser­vice under the IVDD until May 26, 2026.
  • Class D devices may con­tin­ue to be placed on the mar­ket or put into ser­vice under the IVDD until May 26, 2025.
• Class A devices not requir­ing noti­fied body involve­ment under the IVDR will have to ful­ly com­ply to the IVDR as of May 26, 2022.
• Man­u­fac­tur­ers who may make use of the extend­ed tran­si­tion peri­od must still com­ply to the IVDR require­ments on PMS, vig­i­lance, eco­nom­ic oper­a­tor and device reg­is­tra­tion as of May 26, 2022.
• Man­u­fac­tur­ers who may make use of the extend­ed tran­si­tion peri­od may not imple­ment any sig­nif­i­cant changes to the device design or intend­ed pur­pose. This may be espe­cial­ly chal­leng­ing for soft­ware devices.
• Man­u­fac­tur­ers with noti­fied body cer­tifi­cates issued under the IVDD may con­tin­ue to place their prod­ucts on the mar­ket under the IVDD until the cer­tifi­cate expires under the con­di­tions ref­er­enced above.
• In addi­tion, the Com­mis­sion has pro­posed a deferred appli­ca­tion of the require­ments for devices man­u­fac­tured and used with­in the same health insti­tu­tion, so called “in-house devices”.

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

• Free intend­ed use gen­er­a­tor – an impor­tant tool under the MDR and IVDR
• SARS-CoV-2 IVD tests and the IVDR
• The IVDR and per­for­mance eval­u­a­tion studies
• Key guid­ance doc­u­ment on the clas­si­fi­ca­tion of IVDs under the IVDR