U.K. regulator lays out proposal for international device and diagnostics recognition

Background: The U.K.’s work towards a new medical device regulatory framework

• The U.K. still operates under the European medical device, active implantable and in vitro diagnostic directives (MDD, AIMDD and IVDD, respectively), which were originally transposed into U.K. law as the Medical Devices Regulation 2002 (UK MDR 2002). In 2020, the government amended the law as the Medical Devices (Amendment etc.) (E.U. Exit) Regulations 2020 to address the implications of Brexit.
• Enactment of the Medicines and Medical Devices Act 2021 granted wide-ranging powers to the Secretary of State for Health to create a new regulatory framework for medical devices and medicines, while taking into account safety, availability, and the attractiveness of the U.K. as a place to launch innovative products. The Medicines and Healthcare products Regulatory Agency (MHRA) also has new enforcement powers which allow civil and criminal sanctions for breaches of the Act.
• In late 2021, the MHRA requested public feedback on a proposed new medical device regulation. The proposal covered many of the same topics and regulatory considerations as the E.U. Medical Device Regulation (MDR; Regulation (EU) 2017/745). For example, device risk classification would largely mirror that of the E.U. MDR (I, IIa, IIb, III), with some devices changing classification and others being brought under the regulation for the first time (i.e., certain devices with no medical purpose). The MHRA also proposed to align its definitions for medical devices and IVDs with the International Medical Device Regulators Forum (IMDRF) definitions.
• Other topics covered in the proposal included: the responsibilities of different economic operators (i.e., manufacturers, authorized representatives, importers and distributors), requirements for unique device identification (UDI) to improve traceability, and requirements for UK Approved Bodies (UKABs; akin to Notified Bodies in the E.U.). It would also introduce new requirements for human clinical trials, post-market surveillance and vigilance.
• Notably, IVDs would be regulated under the same proposed regulation. This differs from the E.U., which now has separate regulations for medical devices and IVDs (IVDR; Regulation (EU) 2017/746). That being said, the proposed U.K. regulation still covered many of the same topics as the IVDR, including a new risk classification scheme aligning with the IMDRF, companion diagnostics, and oversight for “in house” devices. “In house” devices are those created and used in a single laboratory, and are known in the U.S. as laboratory developed tests (LDTs).
• The proposed regulation deviated from the E.U. MDR in a number of other ways. The U.K. proposed to continue using the device nomenclature GMDN (Global Medical Device Nomenclature), whereas the E.U. adopted a free version initially used by Italian regulators, the EMDN (European Medical Device Nomenclature). The U.K. also proposed modifying its device conformity assessment routes, codifying only those most commonly used and eliminating those that are rarely used. Additionally, while the E.U. MDR doesn’t directly address environmental sustainability, the U.K. proposal included requirements around the use and safe disposal of devices, as well as mandatory environmental impact assessments and/or waste management responsibilities.
• At a high level, stakeholders supported alignment with E.U. regulations and other international groups. Many voiced a preference for the MHRA to follow the E.U.’s lead closely, especially in the areas of reclassification of some implantable devices, rolling some non-medical products into the device regulations, and strengthening post-market surveillance (PMS).
• Stakeholders also indicated support for a pre-approvals route for innovative devices, as well as a domestic assurance route to recognize approvals from third country regulators. Stakeholders also recommended use of the Medical Device Single Audit Program (MDSAP), supporting any and all efforts toward international harmonization. [Read AgencyIQ’s complete analysis of the feedback on the regulations here.]
• In early 2024, the regulator released its roadmap of the future regulations, which included stakeholder discussions on international recognition.

Now the MHRA has doubled down on international recognition with a new statement of policy intent

• On May 21, the MHRA released its plan for recognition of market access for certain medical devices from “comparable regulator countries” (CRCs). The currently proposed CRCs are the Therapeutic Goods Administration (TGA) of Australia, Health Canada, the E.U. and its national competent authorities, and the U.S. FDA. Presently, the U.K. recognizes the E.U. CE mark in addition to its own UKCA mark, with a plan to continue doing so through 2028 or 2030, depending on the legislation to which the CE mark applies. [ Read AgencyIQ’s analysis of that U.K. policy here.]
• MHRA acknowledges the efficiency inherent to international recognition, stating that “reducing duplication of assessments conducted by comparable regulators will enable regulatory resource, and manufacturer resource, to be focused on more innovative products for the benefit of patient health.” In addition to the routes to market outlined in the statement, manufacturers will still be able to use the UKCA mark.
• To qualify for international recognition, devices and IVDs will need to meet certain requirements. This includes complying with the CRC’s relevant legislation, carrying English labeling and instructions, having a UK responsible person on the labeling, using unique device identifiers (UDI) that meet either U.K. or CRC requirements, and complying with the U.K. post-market requirements (these aren’t yet in force but will be some time in 2024). Electronic devices would also need to meet U.K. requirements for electronics compatibility. The devices would also need to follow any recertification requirements from the CRC.
• Certain devices and IVDs will not be eligible for the program. These include in-house devices, custom-made devices, and products in a CRC already relying on international recognition. Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. will not qualify. The program will also exclude several device types which have been cleared in the U.S. via substantial equivalence (the so-called 510(k) route): Software as a Medical Device (SaMD), AI as a Medical Device (AIaMD), companion diagnostics, and class IIb implanted and class III medical devices.
• International recognition will not produce a UKCA mark. Rather, it will produce a certificate of international recognition which allows access to the Great Britain market. For cases in which the U.S. is the CRC (where approvals and clearances don’t expire), the certificate of international recognition would align with the validity of the associated quality management system certificate (e.g., ISO 13485, Medical Device Single Audit Program (MDSAP)).

The regulator proposes four market access routes that utilize international recognition

• The four proposed market access routes: Recognition and self-registration, reliance, reliance with device-specific requirements, and reliance with abridged assessment and device-specific requirements. The access route used will depend upon the device risk classification under the UK MDR 2002, which MHRA goes on to note might differ from the classification in the CRC that issued the device approval.
• Recognition and self-registration: This pathway applies only to Class I medical devices that are not sterile, that do not have a measuring function, and are not reusable, as well as Class A diagnostic devices. To use this route, the manufacturer must supply a declaration to an appropriate quality management system (QMS) like ISO 13485 or a product-specific equivalent.
• Reliance: This pathway applies to certain devices that comply with E.U. regulations (either the MDR or IVDR). AIaMD devices and other devices for which the classification differs between the E.U. and the U.K. are excluded from this route. MDR reliance includes Class I devices that are sterile, have a measuring function or are reusable surgical devices (Class Is/m/r). It also includes class IIa, IIb and III medical devices. For diagnostics, this includes sterile Class A, as well as Class B, C, and D devices, that comply with the IVDR. To use this route, the manufacturer needs to submit a dossier following the IMDRF “Table of Contents” format or the CRC’s equivalent format. Although MHRA won’t review the full dossier during submission, it may refer to it for post-market concerns. Other requirements include evidence of approval of the product, a PMS plan and report, or a Periodic Safety Update Report (PSUR) as applicable.
• Reliance with device-specific requirements: This pathway will be used for devices complying with either legislation in Australia or premarket approval (PMA) legislation in the U.S. AIaMD devices and devices where the classification differs between the CRC and the U.K. are excluded from this route. Reliance with device-specific requirements applies only to medical devices of Class Is/m/r, IIa, IIb and III. Similar to the reliance pathway, the manufacturer needs to use the IMDRF “Table of Contents” format or CRC equivalent for the dossier and have evidence of approval. Other required documentation includes a PMS plan, PMS report or PSUR, any implant cards, and patient information leaflets. For class III and implanted devices, the documentation must also include a summary of safety and clinical performance (SSCP).
• Reliance with abridged assessment and device-specific requirements: This pathway primarily applies to devices with approvals or clearances in the U.S. or Canada. These include medical devices with risk Classes Is/m/r that have licenses in Canada or de novo or 510(k) clearance in the U.S. It also applies to certain risk classes and device types in Australia and the E.U. Notably, acceptance of the U.S. 510(k) clearance applies only to IVDs of Class A (sterile), B, C, or D, and medical devices of risk class IIa or certain types of IIb – non-implants or well-established technologies (WET). (Note: The E.U. MDR definition for WET in Article 52(4) includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.) This pathway requires the same documentation as the reliance with device-specific requirements pathway. Additionally, for Class C and D IVDs the documentation must include a summary of safety and performance. MHRA will review clinical evidence on a sampling basis. For AIaMD, the regulator will review training and test data, verification and validation and the predetermined change control plan (PCCP).
• The table below lists the risk classes applying to each CRC and approval type for reliance with abridged assessment and device-specific requirements.

Table 1: Reliance with abridged assessment and device-specific requirements by country approval type

Other important things to know about this statement of policy intent

• This policy is a draft. It would come into force at the same time as the future core device and diagnostics regulations, which are expected in 2025 according to the regulatory roadmap. MHRA is still working through operational aspects in collaboration with stakeholders, such as who reviews the documentation.
• This proposed framework is currently being assessed using real products. In order to establish processes and create guidance, the MHRA is working through a range of device types and classifications in collaboration with up to 10 industry partners, UK Approved Bodies, and bodies in the process of approval, as mentioned in an MHRA blog from late April.
• Plans for transitioning the UKCA mark: In conjunction with the upcoming core regulations, the government is working to establish transitional arrangements for devices with UKCA marks under the UK MDR 2002. This would allow those products to remain on the market either until: 1) the certificate expires, or 2) three years after the new regulations take effect for medical devices and five years for IVDs. Similar to the E.U. transitional periods for the MDR and IVDR, devices that undergo significant changes would not be able to make use of the transitional period; post-market requirements under the new PMS regulations will apply to all products using the transitional period.
• Possible exemptions for certain devices with CRC approvals: MHRA is considering exempting certain devices with CRC approvals, in the interest of public health. Stakeholders that would like their devices to be considered for an exemption should contact mdcc-contingencyplanning@dhsc.gov.uk.

Analysis

• A clear, thorough proposal for international recognition is likely to be welcomed by industry. Although this U.K. framework for international recognition doesn’t eliminate submissions completely, it does significantly reduce the documentation lift on the part of the manufacturer and the review lift on the part of U.K. regulators, especially in the case of devices with a CE mark.
• This policy proposal somewhat mirrors an existing U.K. policy for foreign drug approvals – the International Recognition Procedure (IRP). That program began in January of this year and also allows for recognition of approval from Japan, Switzerland and Singapore in addition to Australia, Canada, the U.S. and E.U.
• Importantly: This is a draft and is not yet set in law and manufacturers can’t yet make use of this framework. It is intended for release at the same time as the future core medical device regulations, which is currently set for some time in 2025
• It will be important to understand the exemptions and ineligibilities – not all devices and IVDs will be able to make use of these pathways. Makers of custom-made devices, in-house devices, companion diagnostics and combination products would not be able to use this regulatory framework. AIaMD will only be permitted to rely on certain foreign approval types under this regime.
• The amount of documentation will differ according to the foreign regulator that granted market access. E.U. approvals offer the easiest path with the fewest documentation requirements. Next are devices approved in the Australian system or by the U.S. PMA route. Devices with Canadian licenses or those cleared via the U.S. 510(k) route require the most documentation and review by the MHRA.
• The U.S. 510(k) route – which relies on substantial equivalence rather than safety and performance – continues to be a bit of a sticky wicket outside the U.S. This difficulty stems from the fact that the standard for U.S. 510(k) clearance is demonstration of substantial equivalence to a device already on the market, rather than the standard of safety and efficacy (U.S. PMA) or safety and performance (E.U., all risk classes). In order to rely on this type of clearance, MHRA will allow it only for IVDs and well-established medical device technologies. This is something Switzerland has also struggled with in its quest to recognize approvals outside of the E.U.
• How long will the U.K. continue to recognize CE-marked medical devices and IVDs? The current regulations include a sunset date that will fall in either 2028 or 2030, depending on the product type. However, this draft framework appears to be setting up a route towards a form of indefinite recognition of the CE mark for devices and IVDs that will involve, at the very least, greatly reduced regulatory review.

To contact the author of this item, please email Corey Jaseph ( cjaseph@agencyiq.com).
To contact the editor of this item, please email Chelsey McIntyre ( cmcintyre@agencyiq.com).

Key Documents and Dates

• Standard: Statement of policy intent: international recognition of medical devices, published May 21, 2024
• Standard: Implementation of medical device future regime, updated May 21, 2024