Planning and Process for Compliant Post-Market Surveillance
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 once more. This may induce some manufacturers to procrastinate with a number of MDR compliance activities by lulling them into a false sense of security. In fact, a number of new or enhanced requirements under MDR are already enforceable, specifically those relating to Post Market Surveillance, a key pillar of the new Regulation that is closely connected to patient safety.
This blog outlines the importance of thorough planning for PMS success.
MDR extensions for different class devices
Extensions under MDR are 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, with Class A and new devices requiring full compliance from May 2022 and a gradual deadline for devices already on the market that are Class D (May 2025), Class C (May 2026), Class B and Class A Sterile (May 2027).
Current Requirements to take note of now
The following requirements, however, have been active since 26th May 2021i:
- Post Market Surveillance (PMS)
- Periodic Safety Update report (PSUR)
- Post-Market Clinical Follow up (PMCF)
- Person Responsible for Regulatory Compliance (PRRC)
Far from being a good moment for manufacturers to rest on their laurels, this is the perfect time focus on perfecting PMS processes for compliance.
The risk with routine tasks
Routine tasks tend to be easily pushed aside by busy staff whose focus is on their day-to-day activities. Setting specific deadlines to work towards can be a good way of helping to introduce PSM activities firmly into their daily tasks.
It is critical that these are carried out consistently for safeguarding patient safety, as well as company reputation.
Understand your PMS sources
PMS activity is intended to help detect and flag potential issues before they compromise patient safety. As more and more channels and data sources become available it is critical to ensure that PMS processes include thorough, regular monitoring of sources like social media and trade publications as well as user forums and online communities. These new channels are a great resource to help keep track of data on your device, or on similar devices that may experience similar issues. Identifying appropriate data sources and setting up processes for regular monitoring is a first critical step to better PMS.
More competitive medical devices
A thorough PMS plan is also at the core of building processes for better product design and increased competitiveness on the market. Overall building compliance towards the MDR is also crucial to competitive advantage because compliance laggards may not be able to keep up with ‘state of the art’ changes in clinical practice and product feature expectations.
Specialist regulatory consultants
Enlisting the support of specialist consultants who are experts in satisfying post-market obligations should provide ample reassurance that manufacturers are meeting their obligations, are compliant and at the same time, ease the considerable pressures on busy teams.
Discover more in latest whitepaper (LINK) or, alternatively, reach out to us directly for tailored, specialist support that takes the pressure off your in-house teams and write to hello@imedconsultancy.com