8 docs tagged with "mhra-registration"

MHRA annual registration and compliance fees for medical device manufacturers and UKRPs — fee structure, payment, and what happens if fees are not paid.

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.

How manufacturers and UKRPs must maintain their MHRA registration throughout the device lifecycle — when to update registrations, what changes trigger an update obligation, and the consequences of outdated registration.

Which changes to a device, its manufacturer, or its UKRP must be formally notified to MHRA — and which changes are handled through registration update vs. separate notification.

Step-by-step guide to completing device registration via the MHRA Submissions portal — account setup, registration workflow, required information, and common issues.

A practical guide to using the MHRA Submissions portal for device registration, UKRP registration, vigilance reporting, and FSCA notifications — who needs an account, how to set one up, and what the portal is used for.

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.

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.