Amend­ing Reg­u­la­tion (EU) 2024/1860 on the exten­sion of IVDR tran­si­tion peri­ods and ear­ly EUDAMED launch has been pub­lished in the Offi­cial Jour­nal of the EU (OJEU) on July 9, 2024. The lat­ter marks the date of entry into force.

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 for lega­cy devices under the amend­ing reg­u­la­tion are:

IVD Risk Class under IVDRNew 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 to meet the orig­i­nal IVDR com­pli­ance dead­lines of 26 May 2022. 

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.

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. These can be found under arti­cle 110 of the amend­ed IVDR. Addi­tion­al guid­ance can be found here.

Eudamed

Amend­ing Reg­u­la­tion (EU) 2024/1860 also pro­vides for a change in approach regard­ing Eudamed. For­mer­ly, an oblig­a­tory use of Eudamed only applied, once the data­base with all its planned mod­ules was ful­ly func­tion­al. With the amend­ing reg­u­la­tion, a grad­ual and com­pul­so­ry imple­men­ta­tion of Eudamed is pro­vid­ed for. As soon as indi­vid­ual mod­ules are ruled func­tion­al, they become oblig­a­tory – with­out wait­ing for the full set of six to be ready for a sin­gle launch. 

Guid­ance and fur­ther details will become avail­able here short­ly. A recent­ly pub­lished pre­sen­ta­tion lays out the fol­low­ing deadlines:

– manda­to­ry use of the actor, UDI, device and Certs/NBs/market sur­veil­lance mod­ules begin­ning 2026 (4 mod­ules)
– manda­to­ry use of vig­i­lance mod­ule first half 2026 (1 module)

The pre­sen­ta­tion can be found here.

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. Fur­ther guid­ance is expect­ed to be pub­lished short­ly under this link.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website