MEDICAL DEVIC E S
Ten steps to an efficient PMCF plan
The European Medical Device Regulation 2017/745 (EU MDR) has put more emphasis on Post-Market Clinical Follow-up (PMCF), to ensure patient safety. Celeste Maksim outlines some key steps to help manufacturers map out a smooth compliance journey and avoid a dangerous shortage of devices hitting the market.
The European Medical Device Regulation 2017/745 (EU MDR) has put more emphasis on Post-Market Clinical Follow- up and on a lifecycle approach to safety, consequently increasing expectations for data quantity and quality. Yet, even with the additional year to prepare for EU MDR compliance, many of the pre-pandemic challenges, such as the limited number of notified bodies, remain. Post-Market Clinical Follow-Up (PMCF) falls within the Post-Market Surveillance (PMS) plan, which is given greater importance under the MDR. According to the PMFC Plan Template drafted by the Medical Device Coordination Group (MDCG),1
the aim of the PMCF plan is to: confirm the safety and
performance, including the clinical benefit if applicable, of the device throughout its expected lifetime; identify previously unknown side-effects and monitor the identified side- effects and contraindications; identify and analyse emergent risks on the basis of factual evidence; ensure the continued acceptability of the benefit-risk ratio; and, finally, to identify possible systematic misuse or off-label use of the device with a view to verifying that the intended purpose is correct. Needless to say, this process requires a considerable amount of time and resources, and, in a context of post-pandemic budget pressures, cost-effective planning becomes even more essential. This article sets out ten key steps that will aid manufacturers in
adopting best practices in PMFC activities from the very beginning of the PMFC compliance journey, thus ensuring a steady supply of products remains available to hospitals and patients.
Early to rise…
The EU Medical Device Regulation’s application deadline has come and gone, and while manufacturers were given the chance to renew their certificates under the Medical Device Directives (MDD), it is important to remember that Article 120 of the MDR states that post-market requirements will apply to MDD certified devices during the transition period ending in 2024.
PMCF 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. In fact, the earlier medical device companies start the transition the better, particularly due to the high number of devices needing to achieve compliance, the limited number of notified bodies, the ongoing need to interpret regulation provisions, and the additional resource burden all this will cause.
Develop an efficient strategy Considering the greater importance given to PMCF under the MDR, companies should develop an efficient, adaptable strategy. This strategy should incorporate clinical, post-market/quality, business, and operational perspectives, for a holistic approach. For the follow-up activities themselves, manufacturers should carefully evaluate all available options, such as randomised clinical trials (RCTs), registry studies, retrospective patient record reviews, literature reviews, end-user surveys, and focus groups.
48 l
WWW.CLINICALSERVICESJOURNAL.COM JUNE 2022
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