Podcast : décembre 2023
Podcast : l’actualité de la fin d’année, avec Audrey Gilbert !
France
- Macron / France 2030 : Santé | IA
- GMED : Combined audits MDD/AIMDD and MDR : requirements and impact on the quality management system
- S95B et ISO TC 210
Europe
- 2 nouveaux organismes notifiés pour le RDM
- Team-NB : durée de vie
- Study supporting the monitoring of availability of medical devices on the EU market – Surveys for MD and IVD manufacture
MDCG
updates
- MDCG 2019-7 – Rev 1 : Guide relatif à la personne chargée de veiller au respect de la réglementation (mise à jour décembre 2023) – Erik boude
- MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
- MDCG 2021-27 – Rev.1 – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2023 – Erik re-boude
- MDCG 2022-11 Rev 1 – MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR
new
- MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
- MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies
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