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 Followup 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 sideeffects 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.
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