MHRA Updates Guidelines for the Registration of Medical Devices in the United Kingdom
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on the registration of medical devices, clarifying the requirements for manufacturers, importers, and distributors wishing to place products on the UK market. This update is essential for companies that need to navigate the post-Brexit regulatory landscape, ensuring compliance with current requirements.
Key Changes in Guidance
Who should register?
Manufacturers based in the UK of medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices.
Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) to carry out registration on their behalf.
Deadlines and Classification of Devices
The deadlines vary depending on the risk class of the device (Classes I, IIa, IIb, III and IVDs).
The transition to the UKCA mark is underway, but devices with the CE mark may still be accepted under certain conditions until the end of the transition period.
Registration Process
Registration must be done through the MHRA DORS (Device Online Registration System).
Mandatory documentation includes CE/UKCA certificates, conformity assessments, and UKRP details (if applicable).
UKCA marking vs. CE marking
The UKCA mark is mandatory for devices placed on the market in Great Britain (England, Scotland, and Wales).
The CE marking remains valid in Northern Ireland, which follows the EU MDR/IVDR rules, also requiring a designated UKRP.
The MHRA has also reinforced guidelines on enforcement and compliance, increasing control over unregistered devices and clarifying situations that require resubmission for registration.
With regulatory changes underway in the UK, manufacturers should act early to ensure compliance and avoid obstacles to placing devices on the market.
