On 13 March 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on registering medical devices and in vitro diagnostic (IVD) devices in the UK. The update, among others, explains re-registration requirements, provides new guidance links, and clarifies the validity for Letter of Designation issued to UK responsible persons.
MHRA re-registration requirements and fees
The MHRA guidance now specifies that certain changes to registered device characteristics require re-registration. For re-registrations, a statutory fee applies. In particular, a fee applies to modifications such as device class, sterility status, trade or brand name, unique device identifiers (UDIs), including field that cannot be updated in the Device Online Registration System (DORS), and others. Manufacturers must ensure compliance by completing the re-registration process where necessary.
Updated reference guides for account management and device registration
The MHRA has included references to guidance on the EU In Vitro Diagnostic Regulation (IVDR) transition extension under Article 110 for IVD device registration. These documents provide essential instructions for navigating the MHRA’s registration system.
Manufacturers can access the newly updated:
Account Management Reference Guide (March 2025)
Device Registration Reference Guide (March 2025)
Letter of designation validity for UK responsible persons
The Letter of Designation issued to a UK responsible person (UKRP) must be a legally binding contract, confirming exclusive representation and specifying the mandatory regulatory tasks undertaken on behalf of the manufacturer. There is now the further clarification that the validity period of the letter must align with the duration of the contract between the UKRP and the manufacturer, with a maximum term of five (5) years.
If you do not want to miss any MHRA regulatory updates, visit Obelis.UK
Georgios Mariolos
RII Junior Consultant
17/03/2025
References:
MHRA (2025). Register medical devices to place on the market. Retrieved on 13/03/2025.