On 21 May 2024, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published a ‘Statement of policy intent’ to explore a new framework for recognition by the UK of international regulators’ approvals of medical devices.

The announcement coincides with the MHRA’s approach in the medicines space and the recent adoption of the new International Recognition Procedure in January 2024.

The introduction of the new framework aims to:

• prioritise patient safety;
• enhance patient access to necessary medical devices; and
• ensure that the UK remains an attractive market for MedTech innovators.

In this insight piece we summarise the key takeaways for manufacturers of medical devices navigating this evolving landscape.

The proposed framework

Under the proposed framework the MHRA intends to recognise regulatory approvals in Australia, Canada, EU / EEA or the USA (together, the Comparable Regulator Countries, “CRCs”) depending on the device type, class and prior approval. The list of CRCs remains under review and discussions are ongoing to explore the recognition of medical device approvals from Japan.

The proposed framework is currently in draft form and is set to be introduced simultaneously with transitional arrangements for UKCA marked devices and future core regulations in 2025. The MHRA’s objective is to implement a ‘smarter form of regulatory oversight’ which relies on comparable regulators to avoid duplication of assessments and produce ‘predictable, faster approvals improve access to quality assured medical devices for patients.’

How will international recognition work?

The proposed framework outlines the potential access routes to market, which vary depending on a device’s classification under the UK Medical Device Regulations. The scope of this article does not cover the different proposed access routes available to market based on the device’s classification.

In short, the proposed framework aims to provide a less burdensome route to market for manufacturers by allowing medical devices to be recognised without being subject to the full UK authorisation process.

Further to the requirements of specific access routes, all medical devices will be required to:

• comply with relevant legislation in a CRC;
• have English language labelling and packaging;
• comply with GB requirements for electronics compatibility, units of measurement, and labelling materials of concern where applicable;
• align with the device that is currently recognised and authorised in the CRC;
• have a UK responsible person, the name and address of which will be included on the label;
• 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.

If the above conditions and the relevant requirements of the respective access route to market are satisfied, manufacturers will obtain a certificate of international recognition – which is different from a UKCA mark. Eligible medical devices will be granted market access in accordance with the validity of the supplied for the CRC (which must be re-certified when their original certificate, if applicable, expires) or where the CRC permits indefinite market access (such as in the USA) in accordance with the quality management certificate.

Manufacturers opting for this route to market will be required to devise a plan for how to achieve this, in terms of conformity of the product with the proposed framework, including labelling/packaging if the products are not being produced in the UK.

The MHRA will continue to recognise EU-based CE certifications and approvals until 30 June 2030 (at the latest). Manufacturers could alternatively choose to use the UKCA marking to sell their products in the GB market.

Exclusions

• Excluded Medical Devices: The statement also specifies that certain medical devices will be excluded from recognition under the framework – notable omissions include Software as a Medical Device (“SaMD”) and certain higher risk devices, namely Class IIb (non-well established technology (“WET”)) implantable and Class III devices.
• Northern Ireland (NI): The proposed framework only applies to medical devices in Great Britain (GB) only and does not apply to NI (where EU law continues to apply). Qualifying NI Goods may continue to be placed on the GB market on the basis of a valid EU-based CE mark on an indefinite basis. It is hopeful that NI may benefit from the proposed framework in the future, which in turn would reduce the existing requirements on manufacturers navigating the landscape, given the complexity of the current situation.

Key takeaways

The statement of policy intent signals an important development towards a new regulatory framework for medical devices in GB. The proposed framework is promising and represents a more efficient approach towards the use and allocation of resources - by seeking to encourage suppliers to prioritise innovation and overarchingly, patient safety. The MHRA’s approach to share their regulatory strategy for the UK market allows manufacturers to consider in advance if their devices will be eligible for the alternative routes to market and whether they can benefit from streamlined access to the UK market.

If you require any help navigating the relevant rules, regulations and/or commercial considerations when manufacturing or supplying medical devices in the UK market, please get in touch Fiona Nicolson or Joanna Fulton in our Healthcare & Life Sciences team, who would be delighted to help.

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