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Standardisation mandate now sent to CEN/CENELEC

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has now published the standardisation mandate for the harmonisation of standards under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) in the European Standards section of the Commission website.

The mandate is titled: ‘M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council’.

The object of the mandate is described as being: ‘To draft and revise harmonised standards in support of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 and on in vitro diagnostic medical devices’.

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