EU: Two new MDCG guidance documents published – one new, one revised

The MDCG has published two new documents in the form of MDCG 2019-3 rev 1 and MDCG 2020-4.

Revision 1 of MDCG 2019-3 expands on the information relating to Article 54(2)b to include procedural aspects.

The new MDCG 2020-4 presents the options for notified bodies when performing audits under the unique conditions resulting from the COVID-19 pandemic. The guidance contains additional details regarding the implementation of the specified options, which have been developed by the corresponding MDCG working group.