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Statement of policy intent: international recognition of medical devices

Updated 21 May 2024

1. Purpose of this statement

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.

This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

2. Background

The Government response to the 2021 consultation on the future regulation of medical devices in the United Kingdom detailed the intention to proceed with introducing alternative routes to market, which utilises approvals from other countries and Medical Device Single Audit Program (MDSAP) certificates, in addition to the current UKCA (UK Conformity Assessed) marking process.

We currently recognise CE certification and approvals completed by the European Union (EU). This arrangement is time limited until 30 June 2030, at the latest, to support the transition following EU exit. The Medicines and Healthcare products Regulatory Agency (MHRA) also recognises other international regulators’ approvals for medicines.

As supported by the World Health Organization, reliance 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 regulatory resource, and manufacturer resource, to be focused on more innovative products for the benefit of patient health.

Manufacturers of medical devices would still have the option to use the UKCA marking to place devices on the Great Britain market. 

3. Our intended approach

International recognition will allow MHRA to utilise the expertise and decision-making of other regulatory partners for the benefit of patients. MHRA will retain the authority to reject applications if the evidence provided is considered insufficiently robust.

The comparable regulator countries (CRCs) for the proposed framework will be:

Country or jurisdiction	Regulatory authority
Australia	Therapeutic Goods Administration (TGA)
Canada	Health Canada
European Union (EU)	National competent authorities in the member states of the EU/ European Economic Area (EEA)
United States of America (USA)	Food and Drug Administration (FDA)

To be eligible for the proposed framework, according to the proposed access routes described in Section 4, products will need to:

• comply with the relevant legislation in a CRC
• have English language labelling and packaging
• comply with Great Britain requirements for electronics compatibility (frequency, voltage and plug type), units of measurement, and labelling materials of concern where applicable (for example, for substances which are carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1A or 1B, or could result in sensitisation or an allergic reaction)
• have all aspects of the device be in line with the device that is currently authorised in the CRC, including the design, manufacturing process and intended purpose
• have a UK responsible person, the name and address of which will be included on the label (this may be via over-labelling, and MHRA will also investigate the ability for digital labelling or digital label solutions)
• have a physical unique device identifier (UDI) on parts and labels in compliance with the requirements in the UK Medical Devices Regulations or the CRC
• comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations  which are expected to come into force in 2024

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.

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.

Where the CRC allows indefinite market access (such as in the USA), the validity for the certificate of international recognition would be in accordance with the quality management system (for example, MDSAP) certificate.

The following would be excluded from international recognition:

• exempted in-house devices
• custom-made devices
• Software as a Medical Device (SaMD) (including Artificial Intelligence as a Medical Device (AIaMD)) products that do not satisfy our 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 (WET)) 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

The operational aspects of this framework are discussed in Section 6.

4. Proposed access routes

The classifications listed in each proposed access route refer to the classification that will apply under the UK Medical Devices Regulations, which may not be the same as the classification in the CRC.

To determine which access route applies, the manufacturer must first determine which classification applies for their device under the UK Medical Devices Regulations. MHRA has held a webinar which covered our intentions regarding classification of general medical devices and in vitro diagnostic medical devices (IVDs) in the future core regulations.

4.1 Recognition, self-registration with MHRA

This applies for the following devices that comply with devices legislation in any of the specified CRCs (Australia, Canada, EU or USA):

• Class I medical devices, other than Class Is/m/r (Is: sterile; Im: measuring; and Ir: reusable)
• Class A IVDs that are non-sterile

A declaration by the manufacturer to an appropriate quality management system such as ISO 13485 or product-specific equivalent will be required for these devices.

4.2 Reliance

This applies for the following devices, excluding AIaMD and devices where the classification is different in the EU to that under the UK Medical Devices Regulations, that comply with devices legislation in the EU[1]:

• Class Is/m/r medical devices that comply with EU Medical Devices Regulation (EU MDR)
• Class IIa, IIb, III medical devices that comply with EU Medical Devices Regulation (EU MDR)
• sterile Class A IVDs that comply with EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR)
• Class B, C, and D IVDs that comply with EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR)

Manufacturers will need to submit a dossier in the International Medical Device Regulators Forum (IMDRF) ‘table of contents’ format, or equivalent format used in the CRC. The full dossier will not be reviewed during the submission process but may be assessed during the review of post-market events if needed.

Evidence of approval and a PMS plan and associated PMS report or periodic safety update report (PSUR) (where available) will be reviewed.

For AIaMD, or devices where the classification is different in the CRC to that under the UK Medical Devices Regulations, please see Section 4.4.

4.3 Reliance with device-specific requirements

This applies for the following devices, excluding AIaMD and devices where the classification is different in the CRC to that under the UK Medical Devices Regulations, that comply with devices legislation in Australia or premarket approval legislation in the USA:

• Class Is/m/r medical devices
• Class IIa, IIb, III medical devices

Manufacturers will need to submit a dossier in the IMDRF ‘table of contents’ format, or equivalent format used in the CRC. The full dossier will not be reviewed during the submission process but may be assessed during the review of post-market events if needed.

Evidence of approval and a PMS plan and associated PMS report or PSUR (where available) will be reviewed. Manufacturers will need to supply implant cards and patient information leaflets for implantable devices for the UK. A summary of safety and clinical performance will also be needed for Class III and implantable devices.

For AIaMD, or devices where the classification is different in the CRC to that under the UK Medical Devices Regulations, please see Section 4.4.

4.4 Reliance with abridged assessment and device-specific requirements

This applies for the following devices:

• 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 (WET)) medical devices that comply with 510k legislation in the USA
• sterile Class A IVDs that comply with devices legislation in Australia, Canada or Premarket Approval, DeNovo or 510k legislation in the USA
• 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[2], or Premarket Approval or DeNovo legislation in the USA
• any device where the classification is different in the CRC to that  under the UK Medical Devices Regulations

Manufacturers will need to submit a dossier in the IMDRF ‘table of contents’ format, or equivalent format used in the CRC. The full dossier will not be reviewed during the submission process but may be assessed during the review of post-market events if needed.

Evidence of approval and a PMS plan and associated PMS report or PSUR (where available) will be reviewed. Device classification will be reviewed since this route captures devices where the classification is different in the CRC to that under the UK Medical Devices Regulations. Manufacturers will need to supply implant cards and patient information leaflets for implantable devices. A summary of safety and clinical performance will also be needed for Class III and implantable devices, and Class C and D IVDs. Clinical data may be reviewed on a sampling basis, and for AIaMD there will be a review of premarket (training and test) data, implementation verification and validation and use of predetermined change control plans.

5. Qualifying Northern Ireland goods

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. This arrangement is as a result of the government’s commitments to Northern Ireland’s unfettered access to the market in the rest of the UK, and is underpinned by the UK Internal Market Act 2020.

6. Ongoing activities

This proposed framework is a draft and the final version would come into force at the same time as the future core regulations which are aiming to be in force in 2025.

The operational aspects of this framework regarding who the documentation is submitted to, who reviews the documentation, who performs the subsequent post market surveillance and change assessment, and the requirements for these assessments are being developed under trusted advisor principles in stakeholder discussions including industry, designated approved bodies and applicant approved bodies going through the designation process.

MHRA is testing the proposed framework with a range of devices across all classifications and types in collaboration with industry, designated approved bodies, and applicant approved bodies going through the designation process, to establish the process and associated guidance. Please note that market access via international recognition would only be formally granted once the future core regulations are in force and the proposed framework may be updated based on these activities.

Note also that, as outlined in the Government response to the 2021 consultation on the future regulation of medical devices in the United Kingdom, it remains the government’s intention to introduce transitional arrangements for UKCA marked devices with the future core regulations.

The government would like to establish a transitional arrangement for UKCA marked devices which will allow, at a minimum, products to be placed on the market until either the certificate expires or for 3 years after the new regulations take effect (in the case of general medical devices) or 5 years (in the case of IVDs), whichever is sooner.

The caveats that will apply to this arrangement are:

• devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
• all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements

MHRA is also considering exercising, in the interests of public health, the powers in regulation 12(5) for general medical devices, 26(3) for active implantable medical devices or 39(2) for IVDs to provide exemptions for certain devices with current approvals in the specified CRCs. The decision on whether a device may be authorised under these regulations will be made in conjunction with NHS and DHSC. Please contact mdcc-contingencyplanning@dhsc.gov.uk if you would like to be considered for this.

7. Enquiries

If you have general queries about this statement of policy intent, contact us on: info@mhra.gov.uk.

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[1] Please note these requirements do not apply to qualifying Northern Ireland goods, see Section 5 for further information.

[2] Please note that these requirements do not apply to qualifying Northern Ireland goods, see Section 5 for further information.