Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – EMA to launch scientific advice pilot for high-risk devices in late February
The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
Switzerland – Dealing with certification gaps (MDCG 2022-18)
Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...
UK – MHRA increases UK assessment capacity for in-vitro diagnostic devices
UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices,...
Europe – Votre avis sur l’extension de la période de transition des RDM et...
La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of...
Medical devices can be manufactured and used within EU health institutions (in-house
devices), on a non-industrial scale, to address the specific needs of target patient...
Europe – MDR transition delay needs clarification, industry engagement to succeed
Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
