MDCG 2022-18 — MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 — (June 2023)

MDCG 2022-19 — Performance study application/notification documents under Regulation (EU) 2017/746 — (December 2022)

MDCG 2022-18 — MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate — (December 2022)

MDCG 2020-10 — Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form — (October 2022 October 2022)

MDCG 2022-15 — Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD — (September 2022)

MDCG 2022-14 — Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs — (August 2022)

MDCG 2022-12 — Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) — (July 2022)

MDCG 2022-8 — Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC — (May 2022)

MDCG 2021-13 rev.1 — Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR — (July 2021)

MDCG 2021-18 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) — (July 2021)