Medical devices: ask for a regulatory advice meeting from the MHRA

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides a formal regulatory advice service for manufacturers of medical devices and in vitro diagnostic (IVD) devices. This service is designed for complex queries where existing published guidance is not straightforward. It operates under the regulatory framework of the Medicines and Medical Devices Act 2021 and the UK Medical Devices Regulations (UK MDR) 2002, specifically regarding requirements for the Great Britain market. Because this document is a procedural guide rather than an enforcement report, it does not list specific company names, inspection dates, or violations. Instead, it outlines the required actions for those seeking expert input. Manufacturers must first review all relevant online guidance before submitting a formal electronic request form. If the MHRA accepts the request, the applicant must pay a fee of £987 at least two weeks before the meeting date. Key responsibilities for the applicant include providing a short presentation and list of questions at least 14 days before the one-hour meeting. After the session, the organization is required to draft meeting notes and submit them to the MHRA within 15 working days. The MHRA will then review these notes for accuracy and return them within 30 days. The agency emphasizes that this service provides regulatory interpretation rather than design or manufacturing consultancy, and it cannot provide legal advice or insights into future regulations.