Many impor­tant doc­u­ments and guid­ance for the imple­men­ta­tion of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) are still miss­ing. In cer­tain aspects, how­ev­er, things seem to evolve in a direc­tion that could take some pres­sure espe­cial­ly from Noti­fied Bodies.

Four Noti­fied Bod­ies des­ig­nat­ed under the MDR

Recent­ly, two more Noti­fied Bod­ies have been des­ig­nat­ed under the MDR. In addi­tion to bsi and TÜV Süd, the NANDO data­base now also includes DEKRA from Ger­many and IMQ from Italy. Still, this is only a very low num­ber con­sid­ered that only a few months are left until the MDR ful­ly applies and that no Noti­fied Body has been des­ig­nat­ed under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) yet. The lat­ter point is cur­rent­ly con­sid­ered a much big­ger prob­lem than the low num­ber of MDR Noti­fied Bodies.

Some relief for cer­tain types of products?

Against this back­ground, there has been a first state­ment by the Euro­pean Com­mis­sion that they would sup­port ini­tia­tives that would exempt fur­ther device groups from the dead­line of May 26, 2020. The most promi­nent group of devices would be class I reusable sur­gi­cal instru­ments. It seems as if reusable sur­gi­cal instru­ments and poten­tial­ly oth­er devices may make use of the extend­ed dead­line until 2024, which is (up to now) only applic­a­ble for class Im/s, IIa, IIb and III devices.

How­ev­er, for the time being, there is no offi­cial deci­sion at hand. This leaves man­u­fac­tur­ers with the ques­tion if they should plan with cau­tion and stick to what is cur­rent­ly required in the MDR or should they rely on the state­ment above.

Source: Medtech Insight (an Infor­ma prod­uct) 

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