Theme COVID-19 – Audit
Target Audience Notified Bodies, Manufacturers, Subcontractors
Products concerned MD, IVD
Documents mentioned MDCG 2020-4 : Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions.

 

This guidance provides us with many details in the form of questions and answers regarding the implementation of the principles sets in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions. Details are provided on remote audits (initial – scope extension – subcontractor – unannounced audit) and their implementation (communication  tools- duration – information exchange – data retention).