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...
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...
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...
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...
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...