UK Medical Device Regulations 2024: New Post-Market Surveillance Guidance

In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices Regulation 2024 regarding Post-market surveillance (PMS) requirements in Great Britain.

MHRA Issues New PMS Guidance under 2024 UK Medical Device Regulation

Focus on Global Monitoring of Safety and Performance Data:

Among all the key requirements we have defined specific focus area related to responsibility of device manufacturers to monitor global safety and performance data for their medical devices and as well as similar devices (Regulation 44ZF(3)(a)(vi)), as issues with one device may affect the safety of others with similar technology or intended purpose.

What Manufacturers Must Include in Their PMS Systems

MHRA has defined the similar devices as those which share the same or comparable technology and purpose hence manufacturers should include related data in their PMS system. This involves collecting performance data across all markets and reviewing publicly available safety information on competitors’ devices. The manufacturer’s PMS system must therefore include the collection of data on the performance of their device across all markets, and of publicly available information on the safety of competitors’ devices which may have an impact on their own.

Where there are many similar devices on the market, the manufacturer’s device should be compared to devices that not only have the same intended purpose but also the same intended use environment. For example, pregnancy tests are used both within and outside healthcare settings and those for professional use should also be considered relative to their intended purpose and context (for example, emergency department, pre-operative assessments).

How Artixio Helps You Stay Compliant and Ahead

At Artixio we have deep research based comprehensive data collection system & tool, which meticulously gathers performance data from all markets and analyses publicly available safety information on similar devices, ensuring your products meet the highest safety standards.

This proactively monitoring of global data on competitor devices and global trends, helps our client’s devices remain safe, compliant, and trusted in every market.

We would be happy to discuss further your requirements and collaborate to provide our deep research-based intelligence solutions.