In Practice Series - The future Medical Device Regulations within the UK

This article was originally published on Compliance & Risks 'In Practice Series' blog, March 2023. 

This article was co-authored by Clarisse Patel, Litigation Assistant, London. 

On 26 June 2022, the UK’s medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) published their response to the consultation on the “future regulation of medical devices in the UK”, which indicates future wide-reaching change for the UK medical devices regulatory regime going forward.

Introduction

In the UK, medical devices are currently regulated under the Medical Devices Regulations 2002 (MDR 2002), which gave effect in UK law to the following EU Directives (which have since been repealed and replaced at EU level):

• Directive 90/385/EEC on active implantable medical devices.
• Directive 93/42/EEC on medical devices.
• Directive 98/79/EC on In Vitro Diagnostic (IVD) medical devices.

Following the UK’s exit from the EU and the sweeping reform of the medical device regime currently being undertaken at an EU level (more detail can be found here), the MHRA has noted that there is now a unique opportunity for the UK to review the MDR 2002 (which is based on EU retained law) and improve how medical devices and IVD medical devices are regulated in the UK post-Brexit.

As part of this, the Medicines and Medical Devices Act 2021, which came into force on 11 April 2021, vests power in the MHRA to allow them to make amendments to the existing regime in the UK, the MDR 2002.

The consultation

As a first step, on 16 September 2021, the MHRA published a consultation seeking the views of patients, medical device researchers, developers and manufacturers to help shape the future regulations on medical devices. The MHRA’s response to the consultation, which as noted above was published on 26 June 2022, confirmed that the UK’s future Medical Device Regulations will be based on the following five ‘pillars’:

• Strengthening the MHRA’s powers to ensure that patients are kept safe.
• Making the UK a focus for innovation, in particular in respect of developing and introducing innovative medical devices.
• Addressing health inequalities and mitigating biases throughout the medical device product lifecycle.
• Building synergies with both EU and global standards through the use of proportionate regulation which supports businesses.
• Setting world leading standards – Building the UKCA mark as a global exemplar.

In conjunction with the above, the MHRA announced on the 25 October 2022 that the UK’s future Medical Device Regulations will likely be in force by July 2024; following a 12 month extension to the original implementation deadline. This extension is seen to allow time for both the industry and regulator alike to prepare for what are significant regulatory changes for the life sciences industry without compromise to the safe supply of medical devices in the UK.

We currently await the draft text to the UK’s future Medical Device Regulations and will comment further upon receipt of the same.

Whilst the extension has given the sector greater breathing room, it is an opportune time to revisit the proposed future changes for device manufacturers and stress test preparedness.

The UK’s future Medical Device Regulations

The MHRA’s response to the consultation sets out the current intention for the UK’s future Medical Device Regulations, which includes the following changes:

A key theme arising from stakeholder responses to the consultation was that the UK’s future Medical Device Regulations should align with the EU Medical Devices Regulation (2017/745) (EU MDR) to avoid duplicative or divergent requirements and to facilitate the ongoing supply of medical devices to the UK market. Under the World Trade Organisation Technical Barriers to Trade agreement, the Secretary of State will be required to share the draft text of the UK’s future Medical Device Regulations for comment at least 60 days prior to the regulations being laid in Parliament.

We will continue to monitor whether this draft text will in fact align with the EU MDR or whether the UK will pave the way for their own unique regulatory regime going forward.

Transitional arrangements

As noted above, the UK’s future Medical Device Regulations are scheduled to take effect by July 2024, following a 12-month extension to the original anticipated date of force. That being said, the MHRA has confirmed that a phased introduction of the new requirements will take place, including:

• CE and UKCA marked devices: Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the UK market.
• Clinical investigations: Clinical investigations which commence under the MDR 2002 before 1 June 2024 will be able to carry on provided that any additional reporting requirements set out in the future regulations are met, such as in respect of serious adverse events or device deficiencies.

Checklist to limit risk

Companies should always refer to the specific regulations and guidance in place. However, the following general principles may provide some helpful pointers for staying on the right side of the law (subject to any subsequent draft text of the UK’s future Medical Device Regulations being published):

• Manufacturers should undertake a 'readiness' review of their product portfolio to include an analysis of the implications of the UK’s future Medical Device Regulations on device classification and ensure that their medical device conforms with the device’s classification assessment. Manufacturers should use the response document to the consultation as a guide of the changes that will be implemented in the
• Manufacturers whose products are not currently in the scope of the MDR 2002 or who are at risk of a change in classification, should consider whether they may now be brought into the scope and, whether their product meets the more stringent requirements. This is particularly the case for borderline products and aesthetic products claiming no medical purpose. The latter would include dermal fillers, which will now be classified as a medical device.
• There remains a relatively small number of UK approved bodies for carrying out conformity assessments and it is understood that current lead times are long. Therefore, steps should be taken now to put in place assessments where required.
• Manufacturers must have in place an appropriate QMS. Although the MHRA have expressed that they will be providing further guidance on specific requirements, stakeholder responses to the consultation have confirmed that the requirements should align with the EU MDR, EU IVD Regulation and ISO 13485.
• Manufacturers should take steps to ensure that they have, within their organisation, at least one qualified person with qualifications or regulatory experience that exceeds minimum standards that would be set out in the UK’s future Medical Device Regulations. It is the MHRA’s intention to require that SMEs have a qualified person permanently and at their continual disposal to ensure that appropriate regulatory support will be available to them.
• Manufacturers should ensure that their post-market surveillance meets the strengthened requirements which will be outlined in the UK’s future Medical Device Regulations.
• Developing and maintaining good ongoing relationships with the MHRA and conformity assessment bodies will ensure manufacturers are better placed to respond to future regulatory changes.
• Consider and create unity between any newly implemented EU requirement, where possible, to limit differing risk profiles across the regions.