Month: October 2022

MDCG 2020-10 rev.1 Updates

The EU’s Medical Device Coordination Group (MDCG) has updated the previously released MDCG 2020-10 guidance on “Safety reporting in clinical investigations of medical devices” under the framework of the EU Medical Device Regulation 2017/745 (MDR); specifically governed by Article 80. Rev. 1 introduces the following updates: You can access MDCG 2020-10 rev.1 here and the …

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