Statement of Policy Intent: International Recognition of Medical Devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory bodies, while still retaining the authority to reject applications if the supporting evidence is deemed insufficient.
The initial recognition agreements will concentrate on regulators from countries with similar regulatory systems, such as Australia, Canada, the European Union (EU), and the United States (US).
This policy framework applies to medical devices in Great Britain. For guidance regarding the regulation of devices in Northern Ireland, separate information is available.
The proposed framework proposed by the MHRA will provide alternative pathways to market by allowing approvals from international regulatory authorities and certifications through the Medical Device Single Audit Program (MDSAP).These routes will complement the current UKCA (UK Conformity Assessed) marking process, offering greater flexibility for manufacturers.
Currently, the MHRA recognizes CE certification and approvals granted by the EU. This recognition will remain in place until 30 June 2030, providing a transitional arrangement following the UK’s exit from the EU. The MHRA also recognizes approvals from other international regulatory bodies for medicines.
As endorsed by the World Health Organization, relying on the regulatory decisions of trusted international authorities provides a “smarter” approach to oversight. This approach leads to more predictable and faster approval processes, improving patient access to high-quality medical devices.
By reducing the duplication of assessments conducted by comparable regulators, this policy will allow both regulatory and manufacturer resources to be focused on the development of more innovative products, ultimately benefiting patient health.
Manufacturers will still have the option to use the UKCA marking to place devices on the Great Britain market. The proposed framework, however, will introduce a certificate of international recognition that grants devices access to the Great Britain market without conferring a UKCA marking or certification.
Exclusions from International Recognition. The following devices and categories will not be eligible for international recognition under this framework:- Exempted in-house devices
- Custom-made devices
- Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD), that does not meet MHRA’s intended purpose guidelines
- SaMD (including AIaMD) products approved through equivalence to a predicate device (US 510(k))
- Devices approved in a comparable regulatory country (CRC) via a recognition route
- Class IIb (non-well established technology (WET)) implantable devices and Class III medical devices approved via a predicate-based route (US 510(k))
- Companion diagnostics approved via equivalence to a predicate device (US 510(k))
- Companion diagnostics and combination products containing medicinal substances that are not licensed in the UK