Europe – MDCG 2020-17 : Q&A on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions.

This document presents questions and answers on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions.
The issues covered by this document have been identified in the context of the implementation of the principles outlined in the guidance document “MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”1. The questions and answers presented below provide further details on the operational and practical implementation of the principles outlined in the guidance document MDCG 2020-4 and should be read in conjunction with such document…