MHRA Updates Guidance on Medical Device Registration in Great Britain
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance "Register medical devices to place on the market", providing detailed information on the requirements for registering medical devices and in vitro diagnostic medical devices (IVDs) before placing them on the Great Britain market.
The guidance explains the registration obligations for manufacturers, UK Responsible Persons and other economic operators, as well as the processes for maintaining device registrations throughout the product lifecycle.
Medical Device Registration Requirements
According to the MHRA, most medical devices and IVDs placed on the Great Britain market must be registered before they can be supplied.
The guidance outlines the registration requirements applicable to different types of manufacturers and explains when registration must be completed by a UK Responsible Person acting on behalf of non-UK manufacturers.
The document also provides information on the fees associated with device registration and the information required during the submission process.
Role of the UK Responsible Person
The updated guidance reinforces the responsibilities of the UK Responsible Person (UKRP) for manufacturers established outside the United Kingdom.
According to the MHRA, the UKRP is responsible for registering devices with the agency and maintaining the accuracy of registration information throughout the lifecycle of the device.
The guidance also explains the documentation required to demonstrate the appointment of a UK Responsible Person.
Managing Device Registrations
The document provides practical guidance on managing registered devices through the MHRA registration system.
Manufacturers and UK Responsible Persons can perform activities including:
Registering new devices;
Updating product information;
Managing conformity documentation;
Adding or removing products;
Updating obsolete GMDN codes;
Uploading revised Letters of Designation;
Correcting registration data;
Deleting or unregistering devices where appropriate.
Supporting Ongoing Regulatory Compliance
The guidance also explains how manufacturers should maintain registration information following changes affecting their devices or organisation.
According to the MHRA, maintaining accurate and up-to-date registration data supports regulatory oversight and helps ensure that medical devices placed on the Great Britain market remain compliant with applicable requirements.
Relevance for Medical Device and IVD Manufacturers
The updated guidance is particularly relevant for medical device and IVD manufacturers intending to place products on the Great Britain market.
Topics of particular interest include:
Medical device registration requirements;
UK Responsible Person obligations;
Device registration procedures;
Management of conformity documentation;
Registration updates throughout the product lifecycle;
Great Britain market access requirements.
The publication provides practical guidance to help manufacturers and UK Responsible Persons manage device registrations and maintain compliance with MHRA requirements throughout the product lifecycle.
