The Euro­pean Com­mis­sion has just pro­posed a series of 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 doc­u­ment aris­es after strong debate at EU lev­el in Novem­ber and Decem­ber last year. The Com­mis­sion had already react­ed to uneasi­ness that IVDs would not be able to meet the orig­i­nal imple­men­ta­tion dead­lines, by pub­lish­ing an amend­ing reg­u­la­tion which was effec­tive from 25 Jan­u­ary 2022. How­ev­er, the cur­rent pro­pos­al pro­vides for sig­nif­i­cant­ly longer exten­sion periods.

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 D 31 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.

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 could start at the end of 2025 if the pro­pos­al is accept­ed. Work is ongo­ing on the clin­i­cal inves­ti­ga­tions and per­for­mance stud­ies mod­ule which will be intro­duced later. 

Sup­ply of crit­i­cal devices

Regard­ing the oblig­a­tion for man­u­fac­tur­ers to give pri­or notice before dis­rupt­ing the sup­ply of cer­tain crit­i­cal med­ical devices and IVDs, it is hoped that the process will be easy to man­age. Stake­hold­ers sug­gest that the Com­mis­sion and Med­ical Device Coor­di­na­tion Group should use the noti­fi­ca­tions to man­age device sus­pen­sions at the EU lev­el, via dero­ga­tions and oth­er meth­ods. The pro­posed amend­ments should not be an extra finan­cial bur­den on device man­u­fac­tur­ers and should be sup­ple­ment­ed with guid­ance to sup­port the effi­cient imple­men­ta­tion of the pro­posed amend­ments straight away. 

Dis­cus­sions between all stake­hold­ers should car­ried on right through 2024 so that last­ing solu­tions to enhance effec­tive­ness, pro­mote inno­va­tion and improve gov­er­nance can be put in place and hence make the Reg­u­la­tions real­ly work for patients and Euro­pean health systems.

Source: Medtech Insight (an Infor­ma product)

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