On 21 May 2024, the Medicines & Healthcare products Regulatory Agency (“MHRA”) issued a Statement of Policy Intent on International Recognition of Medical Devices (“The Statement”). The Statement describes the UK government’s approach to ensuring the seamless international recognition of medical devices in Great Britain, in order to maintain patient safety and access to innovative healthcare technologies. 

By setting out this policy intent, the MHRA demonstrates its commitment to upholding high standards in healthcare and fostering collaboration on an international scale. 

Current vs. intended approach

The MHRA currently recognises certifications and approvals completed by the EU and a few international regulators.

The intended approach outlined in The Statement, will allow the MHRA utilise the expertise and decision of other comparable regulator countries (CRCs), while retaining the authority to reject applications with insufficiently robust evidence. The CRCs under the proposed framework have been identified as Australia, Canada, the EU, and USA.  By harmonising regulations and improving collaboration with global partners, the UK seeks to create a more efficient and transparent regulatory environment for medical devices. 

The policy intends to establish a robust system for recognising international approvals and certifications, streamlining market access for manufacturers and also addressing challenges that come with international recognition, such as language barriers. To this end, in addition to complying with the relevant legislation in the CRC, devices will need to comply with various requirements that are specific to the UK including but not limited to: having English language labelling and packaging; having a UK responsible person, the name and address of which will be included on the label; having a physical unique device identifier on parts and labels in compliance with the requirements in the UK Medical Devices Regulation or the CRC; and complying with the new post-market surveillance requirements in the UK Medical Devices Regulations (to come into force this year).

The MHRA also notes that certain devices will be excluded from international recognition.

Proposed routes to UK international recognition

There are currently four proposed access routes to UK international recognition and the manufacturer must determine which classification, under the UK Medical Device Regulations, their device falls under. This may not be the same classification as in the CRC. 

1. Recognition & self-registration with the MHRA, which will apply to specific devices that comply with the legislation in any of the specified CRCs. 
2. Reliance on EU legislation, which will apply to specific devices where the classification is different in the EU to that under the UK Medical Devices Regulations, but the devices comply with the relevant legislation in the EU. 
3. Reliance with CRC device-specific requirements, which will apply to specific devices where the classification is different in the CRC to the UK Medical Devices Regulations, but the devices comply with the relevant legislation in Australia or pre-market approval in the USA. 
4. Reliance with abridged assessment and device-specific requirements, which will apply to specific devices which comply with certain legislation in the CRCs or any device where the classification is different in the CRC to that under the UK Medical Devices Regulations. 

Qualifying Northern Ireland devices can indefinitely continue to be placed on the UK market; on the basis of on valid CE marking as underpinned by the UK Internal Markets Act 2020.

Next steps 

The framework is set to come into force at the same time as the future core regulations, which are anticipated to be put into force in 2025. Market access will only be formally granted once the regulations are in force. In the meantime, the MHRA is testing the proposed framework with a range of devices across all classifications and types to establish the process and associated guidance. 

The MHRA is also considering providing exemptions for certain devices with current approvals in the specified CRCs, such as active implantable devices. Additionally, the government is aiming to introduce transitional arrangements for UKCA marked devices with the future regulations. 

Benefits 

Globally convergent regulations have well established benefits, and in the context of medical devices, this would include the development of a transparent, predictable and trusted standard, notwithstanding the jurisdiction. This will in turn expedite access to safe and effective medical technologies.  By harmonising regulatory requirements across different countries, manufacturers can streamline the process of bringing their products to market, reducing costs and time-to-market. This will benefit manufacturers, healthcare providers and patients who can access a wider range of innovative medical devices. 

International recognition also facilitates collaboration among regulatory authorities, fostering information exchange and mutual learning. Ultimately it plays a key role in promoting public health by ensuring that medical devices meet rigorous standards regardless of where they are manufactured or used. 

Moving forward

Industry stakeholders should stay informed about updates and changes to regulations and engage with the MHRA to help shape the future of medical device regulation and ensure continued innovation in this space.