Vigilanza sui DM: aggiornamento della Linea Guida MDCG

da Sandro Storelli | Feb 21, 2025 | Approfondimenti, In evidenza, MDCG-EU, News

La vigilanza sui DM è prevista dal MDR tra gli obblighi dei fabbricanti, che devono adottare procedure operative standard per la segnalazione degli incidenti e il monitoraggio post-market. La Rev.2 della Linea Guida MDCG 2023-3 aggiorna la prima versione,...

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