Background
The MHRA will introduce new Post-Market Surveillance (PMS) requirements starting 16 June 2025, under Statutory Instrument (SI) 2024/1368.
The UK’s PMS regulation introduces requirements such as:
- New vigilance terminology and reporting timeframes
- Requirement to develop a proactive PMS system
- To consider how PMS data impacts other aspects of the device, e.g., design and manufacturing, evaluation of clinical data, risk management
- Trend Reporting, which is the requirement to report if there are any “significant increases in the frequency or severity of incidents involving a device if…that increase could have a significant adverse impact on the required risk analysis” and “any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use [for IVDs]”.
The UK’s requirements are generally aligned with the EU MDR/IVDR, such as vigilance terminology and reporting timeframes. However, there are a few differences between the EU and UK systems. For example, the UK PMS Report (Class I medical devices and Class A & B IVDs) must be produced within 3-years of the device being placed on the market/put into service and updated every 3-years thereafter. Meanwhile, the MDR/IVDR does not define a specific timeframe for PMS Reports, although 3-years is generally considered best practice.
Below we provide free PMS Procedure and PMS Plan templates in Microsoft Word format, which manufacturers may incorporate into their quality system.
UK MHRA vs EU MDR/IVDR Requirements
For a list of differences between the UK and EU, please visit: UK MHRA vs EU MDR/IVDR Post-Market Surveillance – Overview of Gaps/Differences
