EU Clarifies Expectations for Remote Audits

The European Commission’s Medical Device Coordination Group has released new guidance that clarifies expectations for Notified Bodies conducting remote audits during the COVID-19 pandemic.

The guidance offers more details on the practical implementation of principles outlined in an April 2020 guidance that allowed audits to be conducted remotely during the pandemic because of quarantine orders and travel restrictions.

The commission is delaying the implementation of the EU’s landmark Medical Device Regulation until May 26, 2021, and said regulators may use their discretion in allowing some product certificates to temporarily lapse during this time.