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

https://health.ec.europa.eu/document/download/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en?filename=mdcg_2022-4_en.pdf

Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers

https://health.ec.europa.eu/document/download/8e9adf30-71b5-4faf-a8fb-b35ce4804440_en?filename=md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf

Questions and Answers on Custom-Made Devices

https://health.ec.europa.eu/document/download/385d7e20-d8b5-49d0-abd7-8daf269bf1b8_en?filename=mdcg_2021-3_en.pdf

Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

https://health.ec.europa.eu/document/download/f124f630-389e-4c45-90dc-24ec0a707838_en?filename=mdcg_2021-6_en.pdf

Manual on Borderline

https://health.ec.europa.eu/document/download/74e9f1ad-0e61-4b5a-8ac4-aace97d81b32_en?filename=md_borderline_manual_12-2022_en.pdf

Commission Guidance on the content and structure of the summary of the clinical investigation report

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023XC0508(01)