At the recent British Healthcare Trades Association (BHTA) Conference 2024, Laura Squire, Chief Healthcare Quality & Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA), discussed where UK medical device regulation is at now and what the future looks like.

The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.

Laura began by explaining the MHRA’s purpose in delivering the future regulatory framework of medical devices in the UK. Its goal is to deliver a robust and leading regulatory framework that prioritises patient and public safety. In delivering this regulatory framework, the MHRA’s chief goals are to deliver:

• Improved public and patient safety.
• Enhanced transparency of regulatory decision-making.
• Closer alignment with international best practice.

The new regulatory framework has been implemented via a series of Statutory Instruments (SIs), Laura explained. Further details are in the slide below.

Laura also provided details of where MHRA is at now with UK medical devices regulation and plans for 2024-2025. The slides below provide more information.

“We’re trying to be more transparent about our timescales,” Laura commented. “But it’s very difficult to be transparent about timescales when you’re doing legislative work, because there are certain things that are not within our gift in terms of timescales.”

A key point from Laura’ presentation was around international recognition. MHRA recently published a statement of policy intent, which outlined MHRA’s intention to recognise medical device approvals from Australia, the EU, Canada, and USA. It contained further details for the access routes depending on the device type, class, and prior approval.

“We are also working actively with Japan to bring them into the international recognition,” added Laura. “It’s slightly more complex there because of the population and understanding how they apply some of the international standards, but there is no doubt that Japan is a rigorous regulator, so we would trust it.

“We’re calling these comparable regulators, because I don’t like the phrase ‘trust’. It implies we don’t trust everybody else, and we do trust quite a lot of other regulators. It’s about the practicalities of making it work. At the moment, these countries are the ones that we think we can get to work, and we’ve worked with all these countries to try to design the framework.”

MHRA is testing the proposed framework in collaboration with industry and approved bodies, using a range of devices with existing approvals from these countries. Market access via international recognition would only be formally granted once the future core regulations are in force, Laura explained. The proposed framework may be updated based on these activities.

The Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent for international recognition of medical devices on 21 May 2024.

Entitled ‘Statement of policy intent: international recognition of medical devices’, it describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union, and the United States of America depending on device type, class, and prior approval.

The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.

The MHRA’s statement of policy intent focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resource to be focused on more innovative products for the benefit of patient health. This statement will also allow manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.

The proposed framework is still in draft, and the final version would be integral with the future core regulations.

Dr Laura Squire, Chief Quality and Access Officer of the MHRA, said: “Today’s announcement is an important step forward towards a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators.

“We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices.

“We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products.”

To be eligible for the proposed framework, medical devices will need to:

• Comply with the relevant legislation in a comparable regulator country.
• 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.
• Have all aspects of the device be in line with the device that is currently authorised in the comparable regulator country, 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 comparable regulator country.
• 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. MHRA underlines that manufacturers of medical devices would still have the option to use the UKCA marking to place devices on the Great Britain market.

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices.

LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK.

LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).

This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify active implantables (in addition to general medical devices).

Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organisations are stable and able to undertake impartial and objective conformity assessment activities; have an appropriate quality management system; and have the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements.

After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.