According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to deploy an international recognition framework for medical devices that would allow device makers to bring products to the UK more easily.
Phillips made these remarks at the 2024 Medical Device Manufacturers Association (MDMA) Annual Meeting on 19 April. Earlier this year, MHRA replaced its European Commission Decision Reliance Procedure (ECDRP) with a new International Recognition Procedure (IRP) for pharmaceuticals that allow the agency to rely on decisions by select international reference regulators, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, Swissmedic, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Phillips noted that the Chancellor of the Exchequer Jeremy Hunt last year said MHRA would use a “rapid, often near automatic sign-off” system to allow medical products on the UK market if those products were already authorized by regulators in select jurisdictions. He also referenced a blog post from Laura Squire, MHRA’s chief healthcare quality and access officer, from March that indicates that the agency would publish a proposal for international recognition for medical devices this spring…
