Ger­man Medi­cal Tech­no­lo­gy Asso­cia­ti­on reports on the impact which the MDR will have on users and ope­ra­tors of medi­cal devices

Devices for which a noti­fied body needs to be invol­ved for the con­for­mi­ty assess­ment pro­ce­du­re under the pre­vious legal frame­work (MDD/AIMDD) (PDF) may take advan­ta­ge of a tran­si­tio­nal peri­od through May 2025 at the latest, pro­vi­ded their cer­ti­fi­ca­te of con­for­mi­ty remains valid.

This tran­si­tio­nal peri­od also bene­fits all Class I devices (cf. 2nd Cor­ri­gen­dum to the MDR) which will requi­re a noti­fied body for cer­ti­fi­ca­ti­on once the MDR takes effect.

This appli­es to reusable sur­gi­cal instru­ments (new­ly clas­si­fied as Class I) as well as higher-classified medi­cal soft­ware, medi­cal devices which con­tain nano­ma­te­ri­als and substance-based medi­cal devices.

Para­do­xi­cal­ly, this tran­si­tio­nal peri­od gene­ral­ly does not app­ly for Class I devices, i.e. for who­se which, by defi­ni­ti­on, are view­ed as least ris­ky to pati­ents and users, so that fur­ther coope­ra­ti­on with a noti­fied body is unneces­sa­ry. Class I devices are requi­red to ful­ly com­ply with the MDR (PDF) as of 26 May 2020.


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