UK PMS July 2023
New UK Post-Market Surveillance Legislation (MHRA)
As UKRP, we must to inform you that the Medicines and Healthcare products Regulatory Agency (MHRA) has recently published the draft Post-market Surveillance Requirements Statutory Instrument. As anticipated, this draft legislation introduces significant changes to the Post-market Surveillance (PMS) framework.
The MHRA had already indicated its intention to implement new PMS legislation last year, and this draft now sheds light on what the industry can expect. The proposed legislation aims to establish a comprehensive and proactive post-market surveillance system, tailored to the risk associated with each medical device. Gone are the days of reactive approaches, as the focus will now be on systematic and continual assessment of safety data.
Key components of the draft legislation include:
Post-market surveillance system: It must be proportionate to the device's risk, proactive, and continually assessed, ensuring it is not merely a formality but a genuinely effective process.
Criteria for the post-market surveillance plan and report (PMSR): The legislation will outline specific requirements for developing robust surveillance plans and detailed reports.
Shorter reporting timeframes for serious incidents: To enhance patient safety, the new legislation will enforce quicker reporting of serious incidents.
Updated requirements for field-safety corrective actions: The draft will provide clearer guidelines for implementing field-safety corrective actions when necessary.
Periodic Safety Update Reports (PSUR): The legislation will include a defined schedule for PSUR submissions, streamlining the reporting process.
Trend reporting: The draft emphasizes the importance of trend reporting to identify potential safety issues promptly.
Retention period for post-market surveillance documentation: To facilitate audits and ensure traceability, the legislation will specify retention periods for surveillance-related documentation.
The good news for the industry is that the draft UK PMS requirements align with the EU MDR/IVDR, providing a sense of continuity amidst the various regulatory changes and postponements.
Furthermore, we are pleased to offer a complimentary Periodic Safety Update Report (PSUR) Template to assist you in your preparations for the new legislation.
As for the timeline, the World Trade Organization's website indicates a proposed date of adoption in December 2023, with the legislation expected to enter into force in June 2024. This aligns with the MHRA's announcement, stating that the new legislation is anticipated to come into effect in mid-2024.
At AF Pharma, we are committed to helping our clients navigate these regulatory changes seamlessly. We understand the importance of compliance and patient safety, and our UKRP services are designed to support you every step of the way. Don't hesitate to reach out to us for any assistance or further information.
Together, let's embrace this new era of post-market surveillance and ensure the highest standards of safety and efficacy for medical devices in the UK.