On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.

The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.

In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain.  For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines).  The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).

The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations.  It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.

Proposed Approach

While the MHRA currently recognizes EU CE marks, this is time limited until 30 June 2030 (at the latest).  The Statement therefore sets out a permanent “smarter form of regulatory oversight” that will result in more “predictable, faster approvals [that will] improve access to quality assured medical devices for patients.”  Under the proposed plans, the MHRA will utilize the expertise and decision-making of comparable regulator countries (“CRCs”), namelynamely:

• Australia — Therapeutic Goods Administration (“TGA”);
• Canada — Health Canada;
• EU/EEA — national competent authorities in the member states; and
• USA — Food and Drug Administration (“FDA”).

Proposed Access Routes

The proposed framework sets out a number of potential access routes, which vary depending on a device’s classification under the UK Medical Device Regulations (“UK MDR”).

1. Recognition, Self-Registration with MHRA

This route applies to certain Class I medical devices and Class A in vitro diagnostic medical devices (“IVDs”) that comply with device legislation in any of the specified CRCs.  Manufacturers will need to make a declaration to an appropriate quality management system, such as ISO 13485.

2. Reliance

This applies to Class Is: sterile; Im: measuring; and Ir: reusable) (Is/m/r), and Class IIa, IIb, and III medical devices that comply with the EU Medical Device Regulation (“MDR”) and sterile Class A IVDs, and Class B, C and D IVDs that comply with the EU In Vitro Diagnostic Medical Devices Regulation (“IVDR”).  Manufactures will need to submit to the MHRA a dossier (although this will not be reviewed during the submission process), evidence of approval, and a post-market surveillance (“PMS”) plan and associated PMS report or periodic safety update report (“PSUR”) (where available).

3. Reliance with Device-Specific Requirements

This route applies to Class Is/m/r, IIa, IIb, and III medical devices that comply with devices legislation in Australia or premarket approval legislation in the USA.  Manufactures will need to submit to the MHRA 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).  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 reliance 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 Requirement

This applies to:

• Class Is/m/r medical devices that comply with devices legislation in Canada or DeNovo or Premarket Notification (510k) legislation in the USA;
• Class IIa, IIb, III medical devices that comply with devices legislation in Canada or DeNovo legislation in the USA;
• Class IIa, IIb (non-implantable) and IIb (well established technology) medical devices that comply with 510k legislation in the USA;
• sterile Class A IVDs and Class B, C and D IVDs that comply with devices legislation in Australia, Canada or Premarket Approval, DeNovo or 510k legislation in the USA;
• AIaMD that comply with devices legislation in Australia, Canada, EU, or Premarket Approval or DeNovo legislation in the USA; and
• any device where the classification is different in the CRC to that under the UK Medical Devices Regulations.

Manufactures will need to submit to the MHRA 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).  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.

Further to the requirements of specific access routes, all devices will also need to:

• comply with relevant legislation in a CRC;
• have English language labelling and packaging;
• comply with Great Britain requirements for electronics compatibility, units of measurement, and labelling materials of concern where applicable;
• align with the device that is currently authorized in the CRC;
• have a UK responsible person;
• have a physical unique device identifier in compliance with the requirements in the UK MDR or the CRC; and
• comply with PMS requirements in the UK MDR which are expected to come into force in 2024.

What’s Excluded?

The MHRA has indicated that the following will be excluded from the international recognition framework:

• exempted in-house devices;
• custom-made devices;
• 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));
• products granted market access in the CRC via a recognition route;
• 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; and
• products excluded from the scope of UK MDR 2002, listed in Regulation 3, such as medicines, human blood products and cosmetic products.

Interested parties should note that the Statement and proposed framework applies to medical devices in Great Britain only.  Qualifying Northern Ireland Goods may continue to be placed on the market in Great Britain on the basis of a valid CE marking on an indefinite basis. 

If you have any queries concerning the material discussed in this blog or medical devices more broadly, please contact members of our Food, Drug, and Device practice.