France – Le Grand Défi « Dispositifs médicaux numériques en santé mentale »
La méthodologie d’élaboration du plan d’actions du Grand Défi a permis de faire émerger un ensemble de propositions d’actions suite à l’audition de 153 acteurs et...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
International – FDA, Health Canada, MHRA release guiding principles on transparency for machine learning...
The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have released additional guiding principles...
Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG...
The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance
reporting and provide guidance for manufacturers of Urogynaecological Surgical
Mesh Implants used for...
Europe – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices...
Medical devices (MDs) and in vitro diagnostic medical devices (IVDs) are essential for a working healthcare system and play a crucial role in the...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la...
Issu de travaux de concertation menés par la Direction générale de la Santé, ce décret vise à mieux protéger la population des injections illégales...
Europe – Medical devices: Council adopts new measures to help prevent shortages
The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations...
Europe – MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions...
Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/6071, states that devices which are covered by valid...
