MDR: num­ber of noti­fied bodies grows

The num­ber of noti­fied bodies under the MDR is incre­asing at a fas­ter pace this year. The­re were 11 noti­fied bodies at the start of the year and this num­ber has grown to 16 in the last six months, inclu­ding 6 in Germany.

Nevert­hel­ess, the desi­gna­ti­on of noti­fied bodies under the MDR (PDF) has been slug­gish over­all, espe­ci­al­ly con­side­ring that the­re were 75 such bodies in 2013, under the MDD (which had lower requi­re­ments for noti­fied bodies), and regu­la­to­ry pres­su­re on the exis­ting 16 noti­fied bodies will be very strong.

The cur­rent noti­fied bodies can be view­ed here.


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