Dec 8, 2020
The European Commission (EC) published a new guidance document prepared by the Medical Device Coordination Group (MDCG). The guidance, MDCG 2020-17: Questions and Answers related to MDCG 2020-4, addresses disruptions to planned Notified Body physical audits caused by the COVID-19 pandemic and related travel restrictions.
The general purpose of this guidance is to expand upon the information initially published in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notifed Body audits during COVID-19 quarantine orders and travel restrictions. Chief among the concerns of the new guidance is shedding light on the question of how best to conduct virtual/remote audits and those on-site audits that are deemed necessary.
MDCG 2020-17 is divided into sections addressing:
This Q&A document appears in the wake of calls by medical device industry groups (such as a position paper issued by MedTech Europe) for the EC and member states to allow virtual audits under the MDR/IVDR in the context of a pandemic. A Team-NB position paper based on a survey of Notified Bodies argued that remote audits provide a satisfactory and effective method for detecting nonconformities.
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