The Euro­pean Com­mis­sion pro­posed a delay of the MDR and sug­gest­ed to post­pone the date of appli­ca­tion for one year due to the cur­rent COVID-19 crisis. 

The Joint Implementation/Preparedness Plan on the new EU med­ical devices reg­u­la­tion (MDR) launched by the Med­ical Device Coor­di­na­tion Group (MDCG) ear­li­er this month did not ful­ly rec­og­nize the chal­lenges the med­ical device indus­try is cur­rent­ly fac­ing. This is what may be read and heard in numer­ous expert rounds these days. 

Although the MDCG acknowl­edges that Noti­fied Body capac­i­ty is chal­lenge, there is was no men­tion­ing of the cur­rent COVID-19 cri­sis with its severe effects on busi­ness includ­ing trav­el restric­tions and oth­er lim­i­ta­tions man­u­fac­tur­ers and oth­er oper­a­tors must cur­rent­ly deal with.

It now appears that the calls for a post­pone­ment of the MDR have been heard. In a press con­fer­ence held on March 25, 2020, the Com­mis­sion said it works on a pro­pos­al to post­pone the date of appli­ca­tion of the MDR for one year. 

It is not clear yet under what con­di­tions this delay might apply and how far-reach­ing the con­se­quences are.

It is not clear yet under what con­di­tions this delay might apply and how far-reach­ing the con­se­quences are. In gen­er­al, all par­ties involved are best advised to care­ful­ly observe the situation. 

We will keep you informed about any sig­nif­i­cant devel­op­ments in this regard.

Source: Medtech Insight (an Infor­ma product)

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