MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...

France – Fonctionnaliser des DM implantables grâce au CO2 supercritique

Le CO2 en phase supercritique (CO2 sc) est un fluide obtenu en chauffant du CO2 liquide au-delà de 31°C et en le mettant sous pression à...

France – France Biotech dévoile la dernière édition de son Panorama HealthTech

Réalisée par France Biotech, l’Association des entrepreneurs de l’innovation en santé, en partenariat avec Bpifrance, Citeline, Euronext et EY, cette édition 2022 regroupe notamment...

France – Longue vie aux implants électroniques

PME basée à La Chaux-de-Fonds en Suisse et fondée en 2016, Coat-X fait partie des leaders européens de l'encapsulation en couches minces à base...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

France – Le Snitem et le BVMed alertent les autorités sur les risques liés...

Avec son colloque intitulé "Nouveau règlement DM : où en est-on ?", jamais le Snitem (Syndicat National de l'Industrie des Technologies Médicales) n'avait réuni...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list

European regulators just updated the harmonized standards list for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) days ahead of its implementation date on May...

Europe – CAMD Statement – 50th CAMD Plenary meeting

In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to...
Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA appoints first new UK Approved Body to certify medical devices since...

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...

USA – FDA launches TAP Pilot to speed access to safe and innovative medical...

The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product...

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