Preparing for the implementation and management of the new device registration fee

We’ve published additional implementation and management guidance to help manufacturers, UK Responsible Persons and Authorised Representatives prepare for the new medical device registration fee, which comes into effect on 1 April 2026.

The guidance explains how the fee will work and what organisations need to do to manage their registrations with the MHRA before placing devices on the UK market. You can also watch a recording that walks through the changes.

Get Ready: New regulations for clinical trials go live on 28 April 2026

28 April 2026 is the implementation date for the new regulations for clinical trials, and we’ve just added guidance about Good Clinical Practice (GCP) to our Clinical Trials hub (CT hub). This New draft guidance covers:

• Declaration of Helsinki and Clinical Trials Regulations alignment
• Archiving and retention of clinical trial records
• Clinical Trials Regulations enforcement provisions

We’ve also published information about ICH E6(R3) Annotations.