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...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
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...
UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
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...
Europe – Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals
A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence...
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...
