There are a total of four UK notified bodies. It doesn't appear that three of them will be ready in time for a no-deal Brexit, likely forcing device manufacturers who use the services to suspend products from the market while the companies change notified bodies, one attorney says.
Manufacturers who rely on one of three notified bodies based in the UK and who have not yet taken steps to obtain certificates from an alternative notified body are unlikely to obtain a new certificate in time for the March 29 Brexit deadline, when a no-deal outcome is looking increasingly likely .
That is the warning from Alison Dennis, life sciences partner at Fieldfisher law firm, who has closely studied the...
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
