MEDICAL DEVIC E S
potential side-effects of compartmentalising activities, it is therefore important that all departments are aware of potential business damage caused by possible non-compliance; align on device priority, submission risk and all available sources of product data; and are involved in PMCF decisions.
The business case for legacy product remediation is often very strong. We’ve learned that executing PMCF for legacy products and lower risk class devices can pose logistical challenges. Lower risk class devices such as surgical instruments and gloves are not likely to be documented in literature, in patient charts, or in registries. Therefore, a PMCF survey may be the best option and then the obstacle to overcome is ensuring that clinician respondents are aware of the brand of product they are using.
Consider doing a trial run In the long term, PMCF will be integrated into PMS and clinical operations. New clinical data obtained through PMCF will be fed into the ongoing clinical evaluation and post-market documents will require continuous updates over time. Putting this strategy in place is helpful for all departments to understand how the data links together throughout the post-market lifecycle. We’ve found Gantt charts by document and data input / source to be very helpful for optimising these strategies, including understanding resource requirements for ongoing EU MDR compliance. It is therefore advisable to draft and test processes with some representative high-priority devices to trial templates, forms, and processes to assess if they will work well across the company.
Reach out to notified bodies and third-party experts Remember that notified bodies are strictly forbidden from offering “consultancy or advice to the manufacturer, the authorised representative, a supplier or their commercial competitor as regards the design, construction, marketing, or maintenance of the products under assessment”.2
There are, however, ethical
opportunities to interact with them that should be leveraged, for instance, to clarify the intent of their questions or the meaning
of nonconformities raised.
It is possible for manufacturers to partner with third party experts with knowledge and experience in this area to develop and implement successful PMFC strategies and therefore avoid significant financial and market access implications down the line.
Planning for PMCF
The European Commission extended the implementation deadline for compliance with the EU MDR to give medical device and in vitro diagnostic manufacturers a chance to achieve full compliance, while also handling business disruption resulting from the COVID-19 pandemic. This delay was a welcome development for the industry, but it placed the date of application closer to the EU In Vitro Diagnostic Medical Device Regulation – making good planning even more essential for manufacturers affected by both regulations. Furthermore, the limited number of notified bodies authorised to validate compliance may find it difficult to keep up with the high volume of manufacturers choosing to recertify their devices under the new directives. The volume of certificates expected to expire in 2024, together with the quality of the submissions themselves, could induce delays in application processing and ultimately create shortages in the availability of medical devices in the EU, with negative impacts on patient outcomes and standard of care. To achieve compliance as smoothly and efficiently as
Post-Market Clinical Follow-Up activities require continual effort to meet the new regulation’s requirements. Now is certainly not the time for manufacturers to be lulled into a false sense of security or to slow down efforts to comply.
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Reference 1 Medical Device Coordination Group Document, MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template: A guide for manufacturers and notified bodies, April 2020
2 European Commission, Medical Devices: Guidance Document, Meddev 2.10-2 Rev 1: Designation and Monitoring of Notified Bodies Within the Framework of EC Directives on Medical Devices, April 2001
possible manufacturers can refer to the steps outlined in this article as a useful reference to start outlining or to further refine their Post-Market Clinical Follow-up strategy. For more helpful guidance on staying on track for EU MDR compliance, download the dedicated PMCF whitepaper from RQM+ at:
https://hubs.ly/H0VJm5q0
CSJ
About the Author
Celeste Maksim, PhD, RAC, is the chief of staff, clinical and post-market practice, at RQM+. She has a PhD in analytical chemistry, a RAC certification, and over a decade of experience in regulated indus- tries including pharmaceuticals, medical devices, and in vitro diagnostic products. Celeste’s main focus at RQM+ is on building and managing PMS & PMCF/ PMPF services.
JUNE 2022
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