Background

The new UK PMS regulation SI 2024 No. 1368 goes into effect next week, as of Monday 16 June 2025.

The regulation introduces new requirements such as 1) updated vigilance terminology and reporting timeframes, and 2) the requirement to implement a proactive PMS Plan and Reports.

To help companies prepare, Casus has developed the following resources: UK PMS Procedure & Plan Templates, and Overview of UK vs EU PMS Differences

New & Updated MHRA Resources

Note: all official PMS (including vigilance) documents are consolidated on the MHRA’s webpage: Medical devices: post-market surveillance collection

New Video Explainer

The video is available: HERE

It is 15 minutes long and provides a high-level overview of the new regulation, including explanations of some new concepts, e.g., ‘PMS period’ and examples of when negative side effects or use error may be reportable.   

New Vigilance Forms Webpage

A webpage housing Manufacturer Incident Report (MIR) and Field Safety Corrective Action (FSCA) documentation is available: HERE

Further, there have been updates to the forms, such as:

Note that there are multiple ways to submit reports to the MHRA: 1) manual completion of the report form directly in the Manufacturer’s Online Reporting Environment (MORE), 2) upload of an XML file into MORE, or 3) Application Programming Interface (API), which allows companies to connect their system with MORE, enabling automated, system-to-system submission of reports.

The above webpage also includes GB XSD Files and XML Files for Testing. These are for companies that submit reports to the MHRA via XML files or automated systems. If you submit your vigilance manually via the web-form in MORE, these are not applicable to you.

MORE Guide Updated – Incident Submissions

The updated reference guide is available: HERE

The updates include:

Otherwise, the user manual remains largely unchanged in steps and scope from the August 2023 version.