MHRA’s Revised Regulatory Roadmap – Updates to the UK Medical Device Regulations

The regulatory landscape for medical devices, including of in vitro diagnostics (IVDs) in the United Kingdom (UK) is undergoing a significant transformation. This article outlines key updates to the UK’s future medical device regulations, their implications for the industry, and guidance for regulatory professionals navigating these changes.

Current Regulations Governing the Sale & Supply of In Vitro Diagnostic (IVD) Medical Devices in the UK

The UK’s regulatory framework for medical devices has evolved in response to Brexit-induced divergence from the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as well as the need to enhance patient safety while supporting MedTech innovation.

Since January 1, 2021, several changes have impacted how medical devices, including IVDs, are placed on the market in the UK.? In Great Britain (GB – England, Wales and Scotland), IVDs are currently regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK?MDR?2002)[1] which remains largely based on the EU Directive 98/79/EC (IVDD)[2].?

Under the Northern Ireland Protocol[3], different rules apply allowing Northern Ireland to continue following EU law.? Thus, CE marking remains mandatory for devices sold in Northern Ireland, the EU, and the European Economic Area (EEA).

Implementation of the Future Regulations

In 2022, the UK government published its “Government response to consultation on the future regulation of medical devices in the United Kingdom”[1], outlining a phased approach to reform the UK MDR.

In early 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) released a regulatory roadmap detailing the 2024-2025 timelines for delivering the new framework.? This roadmap was revised in December of 2024 (version 2.0)[2] to reflect updated timelines.

Key Updates:

1. New Post-Market Surveillance (PMS) Regulations – The PMS statutory instrument (SI) was signed into law in December 2024 and will come into force in June 2025 after a six-month transition period.
2. Pre-Market SI – Changes will include new IVD classification rules, revised conformity assessment procedures, and new IVD approval pathways including international recognition routes. The necessary SI is expected to be introduced to Parliament in late 2025 and come into force in 2026.
3. Software, AI & Digital Mental Health Products – The MHRA is expected to publish new/draft guidance on AI development and deployment, cybersecurity and digital mental health technologies in 2025.
4. IVD Policy Development – New policies and guidance for Exceptional Use Authorisation and Early Access and Use are in development, with a dedicated roadmap expected by Q4 of 2025.

NEW Post-Market Surveillance (PMS) Requirements

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024[6] ?introduced stricter obligations for manufacturers, aligning UK requirements more closely with the EU IVDR and MDR while maintaining unique GB-specific elements.? The MHRA have published guidance[7] to aid in implementation.

Key PMS Changes for IVDs:

• Comprehensive PMS Documentation – Manufacturers must maintain a PMS system, submit detailed PMS plans, and, for certain risk classes, provide Periodic Safety Update Reports (PSURS).
• Stronger Reporting Obligations:Serious public health threats – Report within 2 calendar days after the manufacturer becomes aware.Death or unanticipated serious deterioration in state of health – Report within 10 calendar days after the manufacturer becomes aware.?Anticipated serious deterioration in state of health – Report withing 15 calendar days after the manufacturer became aware.?Field Safety Corrective Actions (FSCAs) – Report immediately upon initiation.Field Safety Notices (FSNs) – Distribute to users and stakeholders without delay to mitigate risks.
• Improved Traceability and Transparency – Enhanced supply chain reporting and tracking obligations to ensure patient safety.
• Risk-Based Compliance Adjustments – PMS requirements vary by:Device type (general IVDs, high-risk IVDs, etc.)Basis of conformity assessment (UKCA, IVDD, or IVDR).

Table 1 reproduces the PMS obligations specific to IVD devices based on conformity assessment[8].? Most requirements are the responsibility of the Manufacturer; however, certain requirements may be delegated to the UK Responsible Person (UKRP)[9].

Exceptions:? The new PMS requirements do not apply to:

• Devices subject to clinical investigation, performance evaluation or exceptional use authorisation in GB.
• Devices discontinued before the SI enforcement date (these remain subject to MED DEV 2.12 PMS requirements[10]).
• Devices placed on the market or put into service in Northern Ireland (NI), which must follow the PMS requirements of EU?MDR?2017/745?and?EU IVDR 2017/746.

The MHRA has published guidance documents clarifying implementation details [11], including stakeholder consultation opportunities through trade associations[12].

Table 1. PMS obligations specific to IVDs*

Transitional Arrangements & Industry Impact

Key Transition Deadlines

Regulatory professionals must monitor the following deadlines[13] to ensure continued market access:

• CE-Marked Devices – Transitional allowances until December 31, 2027 for most IVDs (and medical devices), with risk-class specific phase-out dates through 2030.
• UKCA Marking ?– The UK is shifting towards full UKCA marking adoption, requiring ?manufacturers to transition accordingly.
• Guidance & Support – MHRA has committed to publishing comprehensive guidance, with further updates expected in 2025.

What Regulatory Professionals Should Do Now

To prepare for the upcoming changes, regulatory professionals should:

• Monitor Implementation Timelines – Stay informed on MHRA consultations, SI publications, and transition deadlines.
• Engage with MHRA Guidance – Regularly review PMS updates, UKCA transition arrangements, and new IVD-specific regulations.
• Conduct regulatory gap analyses – ?Identify necessary updates to PMS documentation, quality management systems and labeling.
• Collaborate with Industry Peers – Participate in trade associations, regulatory working groups, and discussions with UK Approved Bodies.
• Plan for UKCA Transition – Develop a clear strategy for transitioning from CE to UKCA marking.

Our Expertise in IVD & Medical Device Compliance

At Beaufort, we offer extensive expertise in IVD regulatory affairs, clinical research, quality management, and market access. Our team of regulatory experts can help you:

• Develop & Implement PMS Systems – Ensure compliance with the new UK PMS requirements, including PMS plans, PSURs, and incident reporting.
• ?Prepare for UKCA Marking – Assist with conformity assessments, documentation updates, and transition planning.
• Regulatory Gap Analysis & Compliance Strategy – Identify compliance gaps and develop gap-closure roadmaps.
• Regulatory Submission Support – Guide you through the MHRA regulatory submission process, including exceptional use authorizations and performance evaluations.
• Performance Evaluation Support – Design clinical and performance evaluation studies to meet new UK and international requirements.
• Training & Consultation – Provide customized regulatory training and consultation.

Final Thoughts

With the UK’s evolving regulatory framework, staying ahead of the MHRA roadmap is critical for IVD manufacturers and regulatory professionals. As a trusted CRO partner, Beaufort is ready to help companies navigate these regulatory changes, maintain compliance, and ensure market access in the UK.

For more information on how Beaufort can support your UK regulatory strategy, contact us directly at [email protected] or provide your contact information here.

Read article on Beaufort's website: https://beaufortcro.com/article/mhras-revised-regulatory-roadmap/

[1] Medicines and Healthcare products Regulatory Agency.? Guidance Regulating medical devices in the UK.? Published 15 January 2025.? Accessed February 5, 2025.? https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#NI.

[2] Medicines and Healthcare products Regulatory Agency.? Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain. Published January 2025. Accessed February 5, 2025. https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf.?

[3] Medicines and Healthcare products Regulatory Agency.? Guidance for retailers: supplying medical devices to Northern Ireland. Last updated 5 March 2021.? Accessed February 5, 2025. https://www.gov.uk/guidance/guidance-for-retailers-supplying-medical-devices-to-northern-ireland#:~:text=A%20key%20part%20of%20the,to%20the%20relevant%20EU%20legislation

[4] Medicines and Healthcare products Regulatory Agency. Government response to consultation on the future regulation of medical devices in the United Kingdom. Published 26 June 2022.? Accessed February 5, 2025. https://assets.publishing.service.gov.uk/media/62b577f6d3bf7f0b00165a32/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf. [1] Medicines and

[5] Healthcare products Regulatory Agency. Medical Devices Regulatory Reform Roadmap to implementation. Version 2.0 (December 2024).? Accessed February 5, 2025. https://assets.publishing.service.gov.uk/media/6759a8827e419d6e07ce2b21/Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf.

[6] The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 – UK Statutory Instruments 2024 No. 1368? Assessed February 10, 2025. https://www.legislation.gov.uk/uksi/2024/1368/contents/made

[7] Medicines and Healthcare products Regulatory Agency. Guidance The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation. ?Published 15 January 2025.? Accessed February 5, 2025. https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation

[8] Medicines and Healthcare products Regulatory Agency. Guidance Post-market surveillance (PMS) obligations by medical device type. Published 15 January 2025. Accessed February 5, 2025.https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type

[9] Medicines and Healthcare products Regulatory Agency. Guidance Post-market surveillance requirements for medical devices: summary of main changes. Published 15 January 2025.? Accessed February 5, 2025. https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes

[10] Guidance MEDDEVs.? Accessed February 5, 2025. https://health.ec.europa.eu/document/download/c1a6aa0b-d8c8-498b-8ed4-9f3c6211896d_en

[11] Medicines and Healthcare products Regulatory Agency.? Guidance The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation. Published 15 January 2025. Accessed February 5, 2025.? https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation.

[12] Medicines and Healthcare products Regulatory Agency. Press release. MHRA guidance on new Medical Devices Post-Market Surveillance requirements. Published 15 January 2025.? Accessed February 5, 2025.? https://www.gov.uk/government/news/mhra-guidance-on-new-medical-devices-post-market-surveillance-requirements

[13] Medicines and Healthcare products Regulatory Agency. Infographic – Timelines for placing CE marked IVDs on the Great Britain market.? Accessed February 10, 2025.? https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf