EC Q&A clarifies guidelines for medical device remote audits

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.

Previous guidance MDCG 2020-4 left questions about remote audits for medical devices

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:

• the scope of MCDG 2020-4,
• the provision of alternative audit methods when on-site inspections are considered unsafe, and
• eligibility criteria and procedural considerations for conducting remote/virtual audits.

Manufacturers and Notified Bodies have expressed support for virtual audits

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.

Related European medical device regulatory resources from Emergo by UL:

• Emergency market access for medical devices and IVDs in Europe
• COVID-19 regulatory news and analysis resource center
• European MDR preparation support and resource center
• European CE Marking strategy for medical devices