Navigating Post-Market Surveillance: How Deviceology Supports You in Meeting UK Requirements


In the ever-evolving landscape of the medical device industry, regulatory compliance remains a constant challenge. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently made amendments to the UK MDR 2002, introducing more stringent Post-Market Surveillance (PMS) requirements. Deviceology is committed to helping you navigate these changes effectively and efficiently. This blog delves into the intricacies of the new PMS landscape in the UK and outlines how Deviceology can be your trusted partner in compliance. For more details, visit our website at [](

The Regulatory Landscape: UK MDR 2002 Amendments

The MHRA has amended the UK MDR 2002 to introduce clearer, risk-proportionate PMS requirements. These amendments aim to improve the quality of adverse incident data reports and bring more consistency for manufacturers in their PMS activities. 

ISO 13485:2016 and PMS

The amendments are in alignment with ISO 13485:2016, which also emphasises the importance of PMS in the lifecycle of medical devices. Deviceology offers consultancy services to integrate these international standards into your PMS strategy, ensuring not just compliance but also a competitive edge in the market.

When Does PMS Apply?

According to the new Statutory Instrument, the PMS period begins from the day the first device of a model is put into service or placed on the market, whichever comes first. This period extends until the end of the lifespan of the last device of that model. During this timeframe, manufacturers must diligently fulfil all PMS obligations, which include creating a comprehensive PMS plan and, where applicable, a Periodic Safety Update Report (PSUR).

Understanding PSUR Timelines

The timelines for submitting PSURs are comparable to those of the EU MDR/IVDR. They are required every year or every two years, depending on the risk class of the device. For Class I (MD) or Class A/B (IVD) devices, the PMS report must be updated every three years until the end of the PMS period for the device model.

How Deviceology Can Assist You

Comprehensive PMS Plans

Our team of regulatory experts can help you develop a robust PMS plan that aligns with both the UK MDR 2002 and international standards like ISO 13485:2016. We offer a step-by-step guide to ensure that your PMS activities are not just compliant but also effective in ensuring patient safety.

Streamlined Reporting Through the MORE Portal

As of 31st August 2023, the transition to the new MORE portal for adverse incidents and vigilance reporting has been completed. Deviceology offers a streamlined process for reporting through this portal, making it easier for you to manage open reports and ensure traceability.

Continuous Updates and Support

Deviceology is committed to keeping you abreast of any further regulatory changes, ensuring that your PMS activities remain compliant and effective.


Navigating the complexities of Post-Market Surveillance in the UK’s regulatory environment is a daunting task, but you don’t have to go it alone. Deviceology is here to offer comprehensive support, from planning to reporting, ensuring that you not only meet but exceed the regulatory requirements.

For more information on how Deviceology can assist you with your Post-Market Surveillance needs, please contact us at or visit our website at