The Euro­pean Coun­cil adopt­ed on May 30, 2024 the Com­mis­sion pro­pos­al made in Jan­u­ary this year. The next step will be the pub­li­ca­tion in the Offi­cial Jour­nal of the EU (OJEU). The lat­ter marks the date of entry into force, which is now expect­ed to apply in June 2024.

As a reminder, three new steps essen­tial to advanc­ing the imple­men­ta­tion of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR):

  1. An addi­tion­al exten­sion of the tran­si­tion peri­ods for lega­cy devices under the IVDR.
  2. Ear­li­er oblig­a­tory imple­men­ta­tion of most parts of the Eudamed med­ical device database.
  3. A pre­req­ui­site for man­u­fac­tur­ers to give pri­or notice before dis­rupt­ing the sup­ply of cer­tain essen­tial med­ical devices and IVD med­ical devices (IVDs).

The new extend­ed tran­si­tion peri­ods pro­posed for lega­cy devices under the Commission’s pro­pos­al text are:

IVD Risk Class under IVDRNew­ly pro­posed exten­sions of tran­si­tion peri­odsFor­mer ends of tran­si­tion peri­ods as of 25 Jan­u­ary 2022
Class D31 Decem­ber 202726 May 2025
Class C31 Decem­ber 202826 May 2026
Class A and B placed on the       mar­ket in a ster­ile condition31 Decem­ber 202926 May 2027

Non-lega­cy devices, i.e. IVDs which do not have a noti­fied body cer­ti­fi­ca­tion under the for­mer IVD Direc­tive (IVDD) or which were not up-clas­si­fied due to changed IVDR clas­si­fi­ca­tion rules, were required to meet the orig­i­nal IVDR com­pli­ance dead­lines of 26 May 2022.

Despite this extra time, it is vital that com­pa­nies con­tin­ue with their preparation. 

Despite this extra time, it is vital that com­pa­nies con­tin­ue with their prepa­ra­tion. There are dead­lines for launch­ing for­mal appli­ca­tion to noti­fied bod­ies and sign­ing writ­ten agree­ments with these test­ing bod­ies, which are cre­at­ed to help keep the manufacturer’s impe­tus going.

Eudamed

The Com­mis­sion also pro­posed a change in approach regard­ing Eudamed. Cur­rent­ly, an oblig­a­tory use of Eudamed only applies, once the data­base with all its planned mod­ules is ful­ly func­tion­al. With the pro­pos­al, the Com­mis­sion is deter­mined to ensure the grad­ual and com­pul­so­ry imple­men­ta­tion of Eudamed. This will hap­pen as soon as indi­vid­ual mod­ules are ruled func­tion­al, with­out wait­ing for the full set of six to be ready for a sin­gle launch. 

Three mod­ules are avail­able for use on a vol­un­tary basis already for the reg­is­tra­tion of actors, UDI/devices, and noti­fied bod­ies and their cer­tifi­cates. Mod­ules on mar­ket sur­veil­lance and vig­i­lance are on sched­ule and should be oper­a­tional dur­ing the sec­ond quar­ter of 2024. Com­pul­so­ry use of these five mod­ules will start at the end of 2025/ ear­ly 2026 depend­ing on the exact date of pub­li­ca­tion in the OJEU. Work is ongo­ing on the clin­i­cal inves­ti­ga­tions and per­for­mance stud­ies mod­ule which will be intro­duced later. 

Sup­ply of crit­i­cal devices

Accord­ing to the amend­ing reg­u­la­tion, med­ical device and IVD man­u­fac­tur­ers are required to pro­vide pri­or notice about any inter­rup­tion of sup­ply of cer­tain crit­i­cal med­ical devices or IVD med­ical devices. They must do this six months ahead and pro­vide the warn­ing to rel­e­vant author­i­ties, health insti­tu­tions, health­care pro­fes­sion­als and eco­nom­ic oper­a­tors to whom they sup­ply the devices. The Com­mis­sion still needs to clar­i­fy how and in which cas­es man­u­fac­tur­ers must noti­fy a disruption.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website