The Euro­pean Commission’s “State of play of joint Imple­men­ta­tion plan on actions con­sid­ered nec­es­sary to ensure the sound func­tion­ing of the new frame­work for med­ical devices under the MDR”, which was revised in July 2020, talks about sub­mit­ting a new stan­dards request to Euro­pean stan­dards bod­ies CEN and CENELEC in the first quar­ter of 2021.

CEN and CENELEC’s neg­a­tive response to the Commission’s May 2020 stan­dards request has caused a big prob­lem for the indus­try. (als Pul­lquote) This is the sec­ond time the stan­dards bod­ies have turned down a stan­dards request in the frame­work of the EU med­ical devices reg­u­la­tion (MDR) and IVD Reg­u­la­tion (IVDR). 

It seems, how­ev­er, that the Com­mis­sion is still con­fi­dent that har­monised stan­dards giv­ing pre­sump­tion of con­for­mi­ty to enable the con­for­mi­ty assess­ment of devices and their cer­ti­fi­ca­tion will be pub­lished in the Offi­cial Jour­nal of the EU through imple­ment­ing deci­sions from the first quar­ter of 2021. Com­mu­ni­ca­tion between all par­ties is essen­tial to avoid loos­ing more time see­ing that the full appli­ca­tion date of the MDR is 26 May 2021 and it dose not look pos­si­ble that any MDR stan­dards will be revised and adopt­ed ear­ly enough for this date.

Source: Medtech Insight (an Infor­ma product)

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