On May 21, 2024, the United Kingdom’s (UK) Medicine and Healthcare Products Regulatory Agency (MHRA) announced their draft policy for recognizing international regulators’ approvals of medical devices. This stems from their response to the 2021 consultation on the future regulation of medical devices in the United Kingdom, which detailed the intention to introduce alternative routes to market into Great Britain.
Currently, medical devices can be marketed in the UK with a CE mark (but only until June 30, 2030, at the latest) or via the UK Conformity Assessed (UKCA) marking process. Once the CE mark is no longer recognized by the MHRA, medical device manufacturers would only have a single route the UK market: the UKCA.
The MHRA acknowledges that relying on the work of other regulators represents a ‘smarter’ form of regulatory oversight, resulting in more predictable, faster approvals to improve access to quality-assured medical devices for patients. Additionally, reducing duplication of assessments conducted by comparable regulators will enable resources (both in industry and in the MHRA), to be focused on more innovative products for the benefit of patient health.
Summary of Proposed Framework
The comparable regulator countries (CRC) from the draft policy are:
United States (US) Food and Drug Administration (FDA)
Australia Therapeutic Goods Administration (TGA)
Canada
European Union (EU)/European Economic Area (EEA)
The four (4) proposed “access routes” are described below. Note, the device classification specified in each of the access routes refers to the classification in accordance with the UK Medical Devices Regulations, not the device classification of the CRC.
1. Recognition, Self-Registration with MHRA
This access route can be utilized by Class I medical devices (other than Class I sterile, Class I measuring and Class I reusable) or by non-sterile Class A in vitro diagnostics (IVDs).
The manufacturer will also need to provide a declaration to an appropriate quality management system, such as ISO 13485.
2. Reliance
This access route can be utilized by:
Class I sterile, Class I measuring and Class I reusable medical devices with comply with the EU Medical Devices Regulation (MDR)
Class IIa, IIb, and III medical devices which comply with the EU MDR
Sterile Class A IVDs which comply with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), and
Class B, C and D IVDs which comply with the EU IVDR.
Manufacturers will need to submit a dossier (although this will not be reviewed during the submission process), evidence of approval in the CRC, and a post-market surveillance (PMS) plan and associated PMS report or periodic safety update report (PSUR) (where available) to MHRA.
This access route excludes Artificial Intelligence as a Medical Device (AIaMD) and devices where the classification is different in the CRC to that under the UK MDRs.
3. Reliance with Device-Specific Requirements
This access route can be utilized by:
Class I sterile, Class I measuring, Class I reusable, Class IIa, IIb and III medical devices which comply with device legislation in Australia or premarket approval in the US.
Manufacturers will need to submit a dossier (although this will not be reviewed during the submission process), evidence of approval, and a PMS plan and associated PMS report or PSUR (where available) to MHRA. Manufacturers will also need to supply implant cards and patient information leaflets for implantable devices for the UK, as well as a summary of safety and clinical performance for Class III and implantable devices.
This access route excludes AIaMD and devices where the classification is different in the CRC to that under the UK MDRs.
4. Reliance with Abridged Assessment and Device-Specific Requirements
This access route can be utilized by:
Class I sterile, Class I measuring, Class I reusable medical devices which comply with device legislation in Canada or have been cleared via De Novo or 510(k) in the US
Class IIa, IIb and III medical devices which comply with device legislation in Canada or have been cleared via De Novo in the US
Class IIa, IIb (non-implantable) and IIb (well established technology (WET)) medical devices which have been cleared via 510(k) in the US
Sterile Class A IVDs which comply with device legislation in Australia or Canada, have been approved via Premarket Application (PMA) in the US, or cleared via De Novo or 510(k) in the US
Class B, C and D IVDs which comply with device legislation in Australia or Canada, have been approved via Premarket Application (PMA) in the US, or cleared via De Novo or 510(k) in the US
AIaMD which comply with device legislation in Australia or Canada, have been approved via Premarket Application (PMA) in the US, or cleared via De Novo in the US, and
Any medical device where the classification is different in the CRC to that under the UK MDR.
Manufacturers will need to submit a dossier (although this will not be reviewed during the submission process), evidence of approval and a PMS plan and associated PMS report or PSUR (where available) to MHRA. Manufacturers will also need to supply implant cards and patient information leaflets for implantable devices for the UK, as well as a summary of safety and clinical performance for Class III and implantable devices, and Class C and D IVDs.
Considerations
Key details of the proposed international recognition approach to consider are:
Utilizing the international recognition approach will provide a medical device entry into the UK market, but will not grant the medical device a UKCA certification.
MHRA will reserve the right to reject any application if the evidence provided is considered insufficiently robust.
The manufacturer will still need to comply with various requirements, such as having a UK responsible person, UK MHRA-specific post-market requirements, Great Britain requirements for electronic compatibility, and more.
Exclusions from International Recognition
The following types of medical devices are excluded from the international recognition route to the UK market:
Software as a Medical Device (SaMD) (including AIaMD) products that do not satisfy MHRA intended purpose guidelines
SaMD (including AIaMD) products approved via a route which relies on equivalence to a predicate (US 510(k))
Class IIb (non-well established technology) implantable and III medical devices approved via a route which relies on equivalence to a predicate (US 510(k))
Companion diagnostics approved via a route which relies on equivalence to a predicate (US 510(k))
Companion diagnostics and combination products containing medicinal substances that are not licensed in the UK
Products excluded from the scope of UK MDR 2002, listed in Regulation 3, such as medicines, human blood products and cosmetic products
Products granted market access in the CRC via a recognition route
Exempted in-house devices
Custom-made devices
If you have any questions regarding the information discussed in this article, or medical devices more generally, please reach out to a member of our team, here.