First harmonised standards under MDR& IVDR are now available!

The European Commission has published in the Official Journal of the European Union (OJEU) the Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council (OJ L 256, 19.7.2021, p. 100). This document contains five references of EN ISO harmonised standards related to the currently applicable regulation on medical devices. In this sense, please note that this list of references . . .

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