The Post-Market Surveillance (PMS) Framework

Following from the recent updates Post-market Surveillance Statutory instrument (SI) has been laid in Parliament. This marks the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA). The legislation priorities enhancing patient safety and providing clarity for medical device manufacturers in Great Britain.

The Post-Market Surveillance (PMS) framework is an essential regulatory mechanism for ensuring the ongoing safety and performance of medical devices once they have been placed on the market. Under the evolving medical device regulatory reforms in the UK and broader global standards (such as the EU MDR and IVDR), the PMS framework is designed to monitor, report, and act on potential risks or issues that arise during the lifecycle of a medical device.

Key aspects of the PMS framework include:

1. Continuous Monitoring: Manufacturers must actively and continuously monitor their devices to detect any potential safety risks or performance issues. This includes gathering data from various sources like user feedback, complaints, and adverse event reports.
2. Risk Management: Based on the collected data, manufacturers are required to assess and manage risks associated with their devices. This can involve corrective actions, design improvements, or even recalls if necessary to protect patient safety.
3. Periodic Safety Update Reports (PSURs): Manufacturers are often required to provide regular safety updates (usually annually) for higher-risk devices. These reports summarize findings from the post-market surveillance activities and include data on any incidents or problems reported.
4. Vigilance Reporting: The framework requires manufacturers to report any serious incidents, adverse events, or product failures to regulatory authorities, such as the MHRA in the UK. This ensures that both regulators and healthcare professionals are promptly informed of potential risks.
5. Post-Market Clinical Follow-Up (PMCF): For certain higher-risk or innovative devices, manufacturers may be required to carry out additional clinical follow-up studies after the device is marketed. This helps gather more data on long-term performance and safety.
6. Corrective and Preventive Actions (CAPA): If any safety or quality issues are identified through PMS, manufacturers are obligated to implement corrective actions to prevent recurrence. This might include revising manufacturing processes, updating instructions for use, or even redesigning the product.

The PMS framework is an integral part of the regulatory lifecycle for medical devices, ensuring ongoing safety and regulatory compliance. It aligns with the goal of the new Medical Device Regulatory Reforms to strengthen patient safety and build a robust regulatory environment in the UK.

For Accellerate, this regulatory milestone will create exciting opportunities to support healthcare providers and manufacturers with solutions that facilitate smoother integration of these updated regulatory demands. Supported by #Medisynq, our web-based clinical data registry and patient reporting platform, we offer comprehensive support in CRO services, project management, KOL recruitment, and post-market surveillance for medical devices, software, and drugs.

To find out how we can help you to overcome the #PMS and #PMCF hurdles, support with data collection, real-time reporting, and secure data storage, reach out to Accellerate expert team at [email protected]