MHRA proposes recognition path for devices cleared by trusted regulators

Editor's note: This article was corrected on 17 October 2024 to clarify the proposed international recognition procedure.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to allow medical devices quicker access to the UK market if they are authorized in a comparable regulator country (CRCs), beginning with regulators in Australia, Canada, the EU, and US.
 
Laura Squire, MHRA’s chief quality and access officer, described the plan as a major step toward developing a medtech regulatory framework that prioritizes patient access and safety and ensures the UK remains attractive to medtech manufacturers.
 
“We will continue to work on how our intended policy on international recognition of medical devices will operate in practice,” said Squire in a statement. “By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so.
 
“At the same time, we remain fully committed to the [UK Conformity Assessed (UKCA)] marking for medical devices,” she added. “We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products.”
 
Since Brexit, the UK government concluded that its lack of resources to review medical devices coming to market could result in regulatory delays compared to other CRCs. As a result, last year, Chancellor of the Exchequer Jeremy Hunt said MHRA would use a “rapid, often near automatic sign-off” system to allow medical products on the UK market if regulators already authorized those products in select jurisdictions. (RELATED: Expert: MHRA expected to launch recognition framework for devices, Regulatory Focus 24 April 2024)
 
Earlier this year, MHRA replaced its European Commission Decision Reliance Procedure (ECDRP) with a new International Recognition Procedure (IRP) for pharmaceuticals that allows 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).
 
In 2021, the UK government said it would consider using alternative market routes for medical devices that use approval processes from other countries and Medical Device Single Audit Program (MDSAP) certificates on top of the UKCA marking process. In its transition away from the EU, MHRA currently recognizes CE certification and EU approvals, but they are set to expire by June 2030.
 
MHRA argued the proposed medtech international recognition plan would reduce duplicating regulatory work conducted by CRCs while saving itself and manufacturers resources. It added that manufacturers could still use the UKCA marking process to get products on the market.
 
Products approved in CRCs would qualify for recognition under the new plan if they meet certain requirements, including having English labeling and packaging, being compatible with the UK’s electrical requirements and units of measurement, and being authorized under a person in the UK. A key requirement is that the devices must comply with new post-market surveillance requirements that are expected to go into effect this year under the UK Medical Devices Regulations.
 
“The proposed framework would provide a certificate of international recognition that will grant devices access to the Great Britain market but would not provide a UKCA marking or UKCA certification,” said MHRA. “Market access for eligible devices would be in accordance with the validity of the supplied certificate from the CRC and must be re-certified when their original certificate, if applicable, expires.”
 
The proposed plan also listed the types of devices that would not qualify, such as exempted in-house devices, custom-made devices, Software as a Medical Device (SaMD) that don’t meet MHRA’s intended purpose guidelines, and SaMDs that use a predicate pathway such as the 510(k) pathway in the US.
 
MHRA is considering adding other CRCs to its proposed international recognition plan and is talking with the Pharmaceuticals and Medical Devices Agency (PMDA) about adding Japan to its list. The agency added Qualifying Northern Ireland Goods (U Exit) will continue to be allowed on the UK market indefinitely based on valid CE markings.
 
MHRA announcement