MHRA Expands Regulatory Advice Access for Manufacturers 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated and expanded its regulatory advice service for medical devices and in vitro diagnostic (IVD) devices, providing a structured mechanism for manufacturers and stakeholders to seek clarity on regulatory requirements where existing guidance may not apply straightforwardly.

Overview of the MHRA’s Updated Regulatory Advice Service

The updated guidance was published on the UK Government’s official portal and reflects the MHRA’s ongoing efforts to support compliance with Great Britain’s medical device regulatory framework.

Purpose and Scope of the Service

The expanded MHRA regulatory advice service is designed to help device manufacturers, developers, and other stakeholders interpret and navigate complex regulatory requirements under Great Britain’s medical device regulations. This includes assistance with regulatory and procedural questions that are not directly addressed by existing published guidance. However, the MHRA emphasizes that this service does not replace formal regulatory approvals or structured dialogue with conformity assessment bodies.

The agency encourages applicants to review all relevant published guidance before submitting an advice request, as enquiries already covered by existing documents will be redirected to those resources. The guidance also clarifies that the MHRA’s advice cannot cover future regulatory developments or provide product-specific consultancy and is limited to regulatory requirements applicable in Great Britain (not Northern Ireland, which remains under EU law).

Application Process and Fees

To request a regulatory advice meeting, applicants must complete an official request form and provide background information and specific questions. Supporting documentation may be submitted via email. Once accepted, applicants receive a link to pay a fee of £987 per meeting, which must be paid at least three weeks in advance to avoid scheduling delays. Meetings are structured as one-hour sessions, beginning with a presentation from the requester and followed by documented advice summaries.

Limitations and Follow-Up

The MHRA underlines that its advice is provided without prejudice and does not override applicable laws or confer market approval. After meetings, participants are expected to submit notes for review and may request clarifications for a further fee, though such requests must remain within the original scope. Formal complaints are handled via the agency’s customer services channels.

Context Within UK Medical Device Regulation

This regulatory advice service complements the UK’s broader regulatory environment for medical devices, overseen by the MHRA, which includes registration requirements and conformity assessments prior to placement on the Great Britain market. All medical devices and IVDs must be registered with the MHRA and comply with the UK Medical Device Regulations, with enhanced post-market surveillance and evolving frameworks in 2025 and beyond intended to ensure patient safety and support innovation.

Benefit for Manufacturers

For manufacturers, this enhanced MHRA advisory service offers a clearer route to resolving regulatory questions that are not fully addressed in published guidance, helping to reduce uncertainty, de-risk compliance decisions, and maintain progress on development and Great Britain market access plans as UK requirements continue to evolve.

How MedEnvoy can Support 

MedEnvoy can help manufacturers maximize the value of MHRA regulatory advice meetings by identifying the right questions, supporting the preparation of a concise dossier, and translating MHRA feedback into a clear regulatory action plan for market access. Our expertise ensures that your MHRA registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support. Contact us so we can assist you.