Standardisation request for the EU MDR & IVDR: update

The European Commission has informed that the Standardisation request from 14.4.2021 in support of Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] has been accepted by the European standardization bodies CEN & CENELEC!

This is the legal basis for development and publication of harmonised standards in the Official Journal of the European Union.

Once published, harmonised standards can be used by manufacturers to demonstrate that their devices comply with relevant legal requirements that are covered by the harmonized standard as we previously reported on our News section.

M/575 Commission Implementing Decision C(2021) 2406 of 14.4.2021 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 containing the text of the standardisation request can be found here.

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