| 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).