EU - new and updated MDCG guidance documents
The MDCG published three new and one updated guidance document in January and February 2023:
MDCG 2023-1 deals with in-house devices under MDR and IVDR,
MDCG 2023-2 details rules for the publication of standard fees by notified bodies,
MDCG 2023-3 is a Q&A document on vigilance under MDR and
in MDCG 2020-16 revision 2 small changes were made with respect to the interpretation of classification rules for IVDs, especially companion diagnostics.