Device Registration Reference Guide

This guide provides instructions for registering, updating, and managing medical devices with the MHRA. It includes details on logging in, submitting applications, handling certificates, and managing existing registrations.

The guide has been updated several times, with minor edits on 13-Mar-2025 and 11-Jan-2024. The August 2024 update introduces improvements such as bulk upload processes, file size limits, and security warnings for template downloads. It also clarifies that custom-made devices under EU MDD or AIMDD cannot be registered in the UK, but may be registered under UK MDR Part II or III. In Northern Ireland, only devices that comply with EU MDR 2017/745 can be registered. Additionally, the Unit of Use UDI DI can now be omitted from templates.

Users can register new devices, update registrations, and manage existing records. The guide provides instructions on uploading self-certification declarations, selecting certificates, and handling expired certificates. Bulk upload options allow for efficient product registration, while version history tracking helps users monitor changes. Before submitting applications, users must review and confirm all details, including payments.

Additional guidance covers the removal of migrated pseudo-GMDN terms, management of manufacturer and importer details, and deactivation of importers when necessary.

Source: https://assets.publishing.service.gov.uk/media/67c9d05c8247839c255ae3fe/Device_Registration_Reference_Guide_March_2025__Final_v1.pdf

Region: Europe