The Euro­pean Com­mis­sion seem­ing­ly wants to catch up with the short­falls of the last years. Late April, the fol­low­ing guid­ance doc­u­ments for Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) have been pub­lished. Please review care­ful­ly as they may be impor­tant for your tran­si­tion, espe­cial­ly regard­ing clin­i­cal evaluations:

Fur­ther­more, in the course of the COVID-19 cri­sis, the Com­mis­sion has issued guid­ance on cer­tain prod­uct types that are urgent­ly required in the giv­en situation:

It is a chal­leng­ing time, which makes it dif­fi­cult to keep track with all devel­op­ments. Should you have any ques­tions, please don’t hes­i­tate to get in touch.

Sources: MDCG guid­ance documents

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