The UK is edging closer to finalizing its regulatory sovereignty from the EU, but success will depend on its ability to keep pace with rapid medtech developments, such as those driven by artificial intelligence (AI).
The Association of British HealthTech Industries (ABHI) warns in a recent report that the “process of initial and ongoing approval, and of post-market surveillance, needs to reflect the rapid pace...
International harmonized standards should be the “default approach” taken to address gaps in the regulatory regime, rather than legislation, the ABHI report says. This is because these documents “can evolve...