Europe – Add 1 – MDCG Position Paper on the application of Art.97 MDR...
The position paper MDCG 2022-18 was published in December 2022 to provide a
uniform approach to the application of Article 97 of Regulation (EU) 2017/745...
Europe – Pediatricians push for urgent action to stop MDR from disrupting medical device...
The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for...
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 – EUDAMED user guide : Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU
medical devices regulations:
Regulation 2017/745 on medical devices
Regulation 2017/746 on in vitro...
Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can...
In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the...
UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
Europe – Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition
Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD...
Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the...
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with...
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...
