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:
- Medical Device Directive 93/42/EEC. It is important to emphasize that the requirements for medical devices laid down in the Directive 93/42/EEC are different from those laid down in the future Medical Device Regulation (EU) 2017/745; therefore, the standards drafted in support of MDD, should not be used to demonstrate conformity with requirements of Regulation (EU) 2017/745;
- Active Implantable Medical Devices Directive 90/385/EEC;
- In vitro diagnostic medical devices Directive 98/79/EC.The Decisions in question can be found on the following link, together with the full list of references of the standards. The Decisions shall remain valid until 2024.
22.04.2020
Nika Gavrilovic
Regulatory Affairs Department
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