Key Changes to Medical Device Registration with MHRA

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented important updates to the registration process for medical devices. Here are the key changes:

1. Re-registration Fee for Certain Device Changes: A fee will now be required for the re-registration of a device if it undergoes any significant changes in characteristics. This includes changes such as:

• • A shift in risk class,
  • Change from non-sterile to sterile (or vice versa),
  • Modification of the brand or trade name,
  • A change in the Unique Device Identifier (UDI), or
  • Any changes to fields that cannot be updated in the Device Online Registration System (DORS).

2. Updated Account Management Information: The account management section has been updated and now includes direct links for easier access to the necessary information for device registration.

3. EU IVDR Guidance on Transition Extension: Relevant links to the EU IVDR guidance have been included, specifically regarding the transition extension under Article 110 for the registration of In-Vitro Diagnostic (IVD) devices with the MHRA.

4. Letter of Designation for UK Responsible Person: A new requirement has been introduced to include a Letter of Designation when registering a device with the MHRA. This letter must be a legally binding contract confirming that the UK Responsible Person is the sole representative acting on behalf of the manufacturer. It should also outline the tasks that the UK Responsible Person is obligated to perform.

For more information, visit the official registration page for medical devices on GOV.UK.

These changes are designed to streamline the registration process and ensure compliance with the updated regulations for medical devices in the UK market.

For guidance on key changes to medical device registration with MHRA, contact us today.