MDCG 2021-25 rev.1 — Application of MDR requirements to " legacy devices " and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC — (October 2024)

MDCG 2021-4 rev.1 — Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 — (September 2024)

MDCG 2024-1-5 — DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence — (June 2024)

MDCG 2022-4 rev.2 — Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD — (May 2024)

MDCG 2024-5 — Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5 — (April2024 April2024)

MDCG 2024-4 — Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix – Performance Study Summary Safety Reporting Form — (April 2024)

This MDCG guidance provides detailed recommendations on the content of the Clinical Investigation Plan (CIP) for medical device clinical investigations conducted under EU MDR (Regulation 2017/745). The document aligns with MDR Articles 62-80 and Annex XV requirements, and complements ISO 14155:2020 (Clinical investigation of medical devices - Good clinical practice). It provides an official template for the clinical investigation synopsis, facilitating review by competent authorities and notified bodies, and reducing the risk of queries during the conformity assessment procedure. Sponsors conducting clinical investigations in the EU should reference this guidance alongside the technical documentation, particularly the clinical evaluation, to ensure compliance with MDR pre-market clinical evidence requirements.

MDCG 2023-7 — Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence — (December 2023)

MDCG 2023-4 — Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components — (October 2023)

MDCG 2020-3 rev.1 — Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023. — (September 2023)