IMed Consultancy, a regulatory and compliance consultancy provider with over 50 years of experience supporting UK and international medical device and in vitro device manufacturers launch and maintain their products on global markets, has pooled in-house expertise to develop a free practical guide to Post Market Surveillance.
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The simple guide, available at: https://imedconsultancy.com, outlines the scope of the task, supporting manufacturers who are still getting to grips with developing a best-practice PMS strategy.
Deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation have been pushed back to the end of 2027 for high-risk devices and to the end of 2028 for medium and certain lower risk devices. Similarly, transition to full IVDR compliance has been rescheduled according to the classification of the device. Instead of leveraging this time to get up to scratch with compliance, experience has shown that far too many manufacturers are being lulled into a false sense of security by expanding deadlines.
In fact, many new or enhanced requirements under MDR are already enforceable, specifically those relating to improving patient safety such as Post Market Surveillance (PMS), Periodic Safety Update Report (PSUR), Post-Market Clinical Follow up (PMCF) and the appointment of a Person Responsible for Regulatory Compliance (PRRC). Medical device manufacturers would thus do well to devote this grace period to focus on perfecting their PMS strategy, specifically focusing on understanding its scope. To this end IMed Consultancy has identified and outlined best-practice concerning five critical activities:
- Engaging with patients and users
- Reviewing current publications in literature and trade channels
- Monitoring social media
- Monitoring competitor product safety performance
- Continually reassessing risk management data
Leeanne Baker, managing director and quality & regulatory consultant, said: “We felt the need to sound a call to action to device manufacturers because our experience in the field shows us that a perfect storm is brewing: on the one hand the continued rescheduling of deadlines, combined with the sheer onus of ongoing, cyclical activities such as PMS, on the other the lack of Notified Bodies and a tendency to focus busy teams on the here-and-now of running a business, are all pushing key compliance activities to the bottom of the agenda. In reality, proactive PMS is already a requirement so now is the perfect time to get to grips with this key part of compliance. Our practical guide tries to help businesses understand the full extent of requirements and offers steps to meeting them successfully to improve patient safety and remain competitive in an ever more complex and crowded market.”
