EU - Current MDCG guidance documents from December 2023

The EU published and updated several guidance documents in December 2023.

Newly published are MDCG 2023-5 concerning qualification and classification of Annex XVI products, MDCG 2023-6 on the demonstration of equivalence for Annex XVI products and MDCG 2023-7 on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and “sufficient level of access” to data needed to justify claims of equivalence. The overall number of guidance documents newly published in 2023 is 7, marking a clear decline compared to previous years.

The EU published updates to MDCG 2021-6 Q&A on clinical investigations, MDCG 2021-27 Q&A on Article 13 and 14 of MDR and IVDR and MDCG 2019-7 on the PRRC according to Article 15 of MDR and IVDR.