Who must register with MHRA
Which entities are required to register with MHRA before placing medical devices on the Great Britain market — manufacturers, UK Responsible Persons, and authorised representatives — and the consequences of failing to register.
Registration via the MHRA Submissions portal
Step-by-step guide to completing device registration via the MHRA Submissions portal — account setup, registration workflow, required information, and common issues.
Device-level registration requirements
What information must be provided at the device level when registering with MHRA — device descriptions, classification, certificate references, and the distinction between registering a device family vs individual models.
UDI — Unique Device Identification (UK)
The Unique Device Identification (UDI) system for medical devices in Great Britain — current requirements, MHRA's implementation timeline, UDI structure (DI and PI), and how UK UDI relates to EU UDI requirements.