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

Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence

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

Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5

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

Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

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

Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components

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.