Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
Europe – New Notified Body Designated Under EU MDR
RISE Medical Notified Body AB
Sweden
Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant...
Est paru le 21 juin 2023 au Journal Officiel de l’Union Européenne le Règlement d’exécution (UE) 2023/1194 modifiant les dispositions transitoires établies dans le Règlement...
Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607...
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional
provisions for certain...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
UK – Software and Artificial Intelligence (AI) as a Medical Device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices...
Europe – EU issues implementing regs for devices without an intended medical purpose
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices...
Europe – European Parliament votes to extend MDR transition period
The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in...
UK – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
