Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register Medical Devices to Place on the Market" that provides detailed instructions on How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
The recent update was concerning fees and actions required to change legislation of a registered device.
A medical device, including an IVD, a custom-made device and system or a procedure pack, must be registered with the MHRA in order to be marketed in Great Britain (England, Wales and Scotland). Registration requirements differ for Northern Ireland.
Manufacturers or UK Responsible Persons based in the UK will be able to register devices with the MHRA, as well as Authorised Representatives based in Northern Ireland (for the Northern Ireland market). Applicants/sponsors must ensure that all information submitted to the MHRA is accurate and current.
Registration is required for applicants/sponsors who sell, lease, lend, or give goods:
Class I, IIa, IIb or III devices you have manufactured
Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
any system or procedure pack containing at least one medical device
custom-made devices
IVDs you have manufactured
IVDs undergoing performance evaluation
Manufacturers from outside the UK do not need to appoint a UK Responsible Person to place medical devices on Northern Ireland's market, but manufacturers from outside the EU or Northern Ireland must appoint an Authorised Representative if they wish to sell their devices in Northern Ireland.
To know more in-depth about the When to register, Fees, Review registration, Making changes to registration, etc click this LINK.
Comments