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Commission publishes the draft standardisation request for MDR and IVDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has released a copy of the draft harmonised standards request to CEN and CENELEC, titled “Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746”, copy available from here.

The previous draft from the Commission received criticism from MedTech Europe (MTE) in March 2019 for the absence of many critical standards, including some horizontal standards that form the basis of compliance for many devices, together with the entire series of IEC 60601-2 particular standards. MTE’s comments on the revised draft are awaited.

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