UK Medical Device Regulatory Consulting

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

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.

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.