MDR Post­pone­ment – Han­dle with Care!

The pro­pos­al for a one-year delay of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) that was pro­posed the Euro­pean Com­mis­sion has been con­firmed by the Euro­pean Par­lia­ment. The last step in the process will be a sign-off by the Euro­pean Coun­cil. This is rather a for­mal­i­ty – as such, experts agree that eco­nom­ic oper­a­tors may adapt their tran­si­tion plans accordingly.

Basic infor­ma­tion about the MDR delay

• The MDR date of appli­ca­tion (DoA) will be delayed to May 26, 2021. Prod­ucts that com­ply with the MDD and AIMDD may be placed on the mar­ket until May 25, 2021 accordingly. 
• The grace peri­od, which has been grant­ed for MDD prod­ucts with a valid CE cer­tifi­cate issues by a Noti­fied Body or for cer­tain class I med­ical devices (e.g. reusable sur­gi­cal instru­ments, inhalers, some sub­stance-based and soft­ware prod­ucts) has not been extended.
• Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) will not be postponed.
• Oth­er dead­lines, e.g. the delayed intro­duc­tion of EUDAMED or UDI label­ing require­ments, have not been men­tioned in the pro­pos­al and are thus not affected.

Hap­py about the post­pone­ment? Act with caution!

Although the post­pone­ment brings some relief for all par­ties involved, man­u­fac­tur­ers and all eco­nom­ic oper­a­tors involved should use the addi­tion­al time wise­ly. Many of the prob­lems we are cur­rent­ly fac­ing are not nec­es­sar­i­ly resolved by an addi­tion­al delay. 

In his recent blog, Erik Volle­bregt appro­pri­ate­ly post­ed that the addi­tion­al time won’t bring and addi­tion­al resources. It is thus very like­ly that Noti­fied Bod­ies will have the same capac­i­ty issues they already have today. 

Also, the Euro­pean Com­mis­sion may not be able to pro­vide eco­nom­ic oper­a­tors with the guid­ance that is urgent­ly need­ed because the COVID-19 cri­sis will keep also pub­lic author­i­ties busy. In sum, things might get even more dif­fi­cult, because the MDR DoA, EUDAMED intro­duc­tion and IVDR DoA will all fall into a very lim­it­ed time frame.

An appeal to all eco­nom­ic operators

Experts have warned broad­ly to not wait until the last minute to com­plete the MDR tran­si­tion. Use the addi­tion­al time and make the most of it. Ear­ly birds will have less prob­lems relat­ed to lim­it­ed capacities.

So please don’t wait until 2021 to set up the required doc­u­men­ta­tion and con­tin­ue with your tran­si­tion process imme­di­ate­ly. This will help you to safe­guard a smooth tran­si­tion process!

Source: Medtech Insight (an Infor­ma prod­uct), med­icalde­vicesle­gal blog

For fur­ther in depth infor­ma­tion on changes accom­pa­ny­ing the new MDR, we warm­ly rec­om­mend our fol­low­ing arti­cles and pages

• Our arti­cle “Lat­est MDCG Pre­pared­ness Plan and MDR Delay”.
• Most Impor­tant Changes on MDR.
• Major Aspects of the MDR.
• Browse our web­site by tag “MDR”.