New 2020 lists of harmonised standards for medical devices made available

On the March 25, 2020, the European Commission implemented 3 Decisions, concerning new lists of harmonized standards for medical devices, in order to accelerate the production of medical devices, in the context of the COVID-19 outbreak.

These harmonized standards are drafted to presume compliance with the essential requirements they cover in support of the following legal acts:


Nika Gavrilovic

Regulatory Affairs Department

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