UK Medical Device Regulatory Consulting

Expert UKCA Compliance Support and MHRA Regulatory Guidance for Medical Devices and Diagnostics

Following the UK's departure from the European Union, the regulatory landscape for medical devices and in vitro diagnostics (IVDs) in Great Britain has diverged from EU rules. Manufacturers must now comply with the UK Medical Devices Regulations 2002 (as amended), secure UK Conformity Assessed (UKCA) marking, and engage directly with the Medicines and Healthcare products Regulatory Agency (MHRA). ProPharma’s team of medical device experts provides regulatory consulting services to support medical device and IVD companies seeking UK market access, compliance, and lifecycle support.

Our team includes former MHRA officials and seasoned UK regulatory professionals who guide clients through every stage of the UKCA process—ensuring efficient market entry and sustained regulatory compliance.

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Comprehensive Regulatory Consulting Solutions for Medical Devices, Diagnostics, and Combination Products in the UK

Regulatory Strategy

Regulatory Meetings

Regulatory Submissions

Preclinical Testing

Market Access

Postmarket Surveillance

UK Regulatory Strategy and UKCA Marking Support

Developing a country-specific regulatory strategy is critical to success in the UK market. ProPharma works with manufacturers to build clear, tailored roadmaps aligned with the UK MDR, classification rules, and MHRA expectations. Whether you're launching a new product in Great Britain or transitioning from CE marking to UKCA, we help define the appropriate route to market and ensure your submission and supporting documentation meet all current regulatory requirements.

Our UKCA regulatory strategy services include:

Classification and regulatory pathway assessment
Gap analysis of CE-marked products for UKCA compliance
Strategic planning for legacy product transition and new product launch
Integration of applicable UK standards and MHRA guidance
Coordination of parallel EU and UK regulatory strategies (where applicable)

MHRA Regulatory Meetings and Correspondence Support

Early and proactive engagement with the MHRA can clarify regulatory expectations, especially for novel or borderline products, devices requiring clinical investigation, or those undergoing significant change. Our team assists clients in preparing for regulatory meetings and formal communications with MHRA to support classification queries, innovation advice, and clinical investigation applications.

Our MHRA support services include:

Preparation of meeting requests and briefing packages
Strategy development for regulatory question framing
Support for responses to MHRA information requests
Clinical investigation consultation and submission assistance
UK Responsible Person (UKRP) liaison services

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UKCA Regulatory Submissions and Approved Body Engagement

Our team of regulatory consultants partners with clients to prepare and manage regulatory submissions for UKCA marking across all device and diagnostic classifications. For higher-risk devices, we provide full support with UK Approved Body submissions, technical documentation, and conformity assessments.

Our UKCA submission services include:

Preparation of UKCA-compliant technical files and documentation
Development and review of Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)
Labeling and IFU compliance with UK requirements
Declaration of Conformity and UKCA certificate support
UKRP documentation preparation and coordination
Responses to Approved Body queries or MHRA requests

Whether your product is Class I and self-declared or requires third-party review, we ensure your UKCA submission is thorough, accurate, and ready for review.

Preclinical and Biocompatibility Testing for the UK Market

UK regulators expect robust preclinical evidence for medical devices and diagnostics entering the market. Our team helps manufacturers plan, execute, and interpret testing strategies that align with UK requirements and internationally recognized standards.

Our testing strategy support includes:

Biocompatibility planning (ISO 10993)
Electrical safety and EMC testing (IEC 60601)
Software validation (IEC 62304) and cybersecurity
Usability and human factors (IEC 62366)
Performance testing and design verification
Risk management integration (ISO 14971)

We ensure that your nonclinical evidence meets MHRA expectations and supports successful UKCA marking.

Gloved hands holding vials near a keyboard and computer monitor in a dark setting

UK Market Access and Reimbursement Strategy

Unlike the centralized EMA model, the UK operates its own health technology assessment and reimbursement systems. ProPharma helps manufacturers navigate the NHS procurement process, prepare for NICE reviews, and explore early access opportunities.

Our UK market access services include:

Reimbursement strategy development for NHS adoption
NICE Scientific Advice and evidence generation planning
Support for NICE Medical Technologies Evaluation Program (MTEP)
Value proposition development and health economic modeling
Early access and accelerated access program guidance

We help ensure that your UK regulatory strategy aligns with reimbursement requirements to support successful commercialization.

Postmarket Surveillance and UK Regulatory Compliance

Postmarket obligations under the UK MDR mirror many of the EU requirements but are managed independently by MHRA. Our team provides full support for postmarket surveillance, vigilance, and ongoing compliance in the UK, including:

PMS Plan and report development
Periodic Safety Update Report (PSUR) creation
Clinical and performance follow-up (PMCF/PMPF)
Vigilance reporting and <abbr title="Field Safety Corrective Action reports ">FSCA</abbr> management to MHRA
Audit readiness and CAPA support
Regulatory intelligence for UK-specific updates and deadlines

We help manufacturers maintain UKCA certification, manage risk, and stay fully compliant with UK regulatory obligations.

Row of professionals working at a conference table

UKCA ready? We are.

Partner with ProPharma to simplify MHRA submissions, achieve UKCA compliance, and accelerate market access.

Speak with a UK Regulatory Expert

Your Trusted Partner for UKCA Regulatory Success

The UK’s evolving regulatory framework presents both challenges and strategic opportunities for medical device and IVD manufacturers. From changing timelines for UKCA implementation to shifting MHRA guidance and requirements for UK Responsible Persons, staying compliant requires not only technical know-how but also agile strategic planning.

At ProPharma, we bring together deep regulatory expertise, former MHRA leadership experience, and hands-on operational support to help manufacturers confidently navigate the UK medical device approval process. Whether you're entering the UK market for the first time, transitioning from CE to UKCA marking, or seeking to maintain postmarket compliance, our consultants serve as an extension of your internal team—anticipating regulatory changes, reducing risk, and accelerating timelines.

Our team of regulatory affairs and medical device experts delivers:

Strategic foresight to align product development with UK MDR and MHRA expectations
Hands-on support for technical file preparation, clinical evaluation, and regulatory submissions
Experienced guidance through MHRA interactions, UKRP coordination, and Approved Body engagement
Integrated lifecycle services that span premarket strategy, market access planning, and postmarket compliance
A tailored approach for every client—startups, SMEs, and global leaders alike

As the UK continues to define its post-Brexit regulatory identity, ProPharma remains a steady, informed partner who helps you make smart, compliant, and commercially sound decisions every step of the way.

ProPharma: The World's Leading Regulatory Consultancy

Ready to bring your device to the UK market—or ensure continued compliance? Contact us today to speak with a UK regulatory expert and discover how we can support your success in the British medical device landscape.

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