The Future of Post-market Clinical Follow-up (PMCF) Under EU MDR as of Early 2026
While the original EU MDR was released in 2017, dozens of guidance documents in the form of Medical Device Coordination Group (MDCG) Guidance have been released since, providing additional clarification about the interpretation and follow-up questions regarding the regulation changes. Additionally, many notified bodies have released white papers describing their interpretation of both the EU MDR 2017/746 and MDCG guidances. Most recently, the European Commission has released a follow-up proposal amending the EU MDR in hopes of reducing the burden on medical device and in vitro device manufacturers, based on feedback from expert panels.
There was a plethora of key takeaways from the late 2025, 170-page proposed amendment, but perhaps the most pivotal to us is an area of the EU MDR we’ve honed in on a lot at Minola Scientific: PMCF.
What Does PMCF Currently Look Like Under EU MDR?
PMCF, or post-market clinical follow-up, under the EU MDR involves a mandatory, continuous process for gathering real-world clinical data to proactively update the clinical evaluation, safety, and performance of a medical device throughout its lifetime. This comes in the form of general PMCF, which is proactive, high-level, or routine postmarket data collection used to confirm long-term safety. General PMCF may come in the form of literature reviews, and or postmarket surveillance collection, such as of sales and complaint data. Moreover, depending on the device type, risk classification, available clinical data, and market history of the device, PMCF requirements may also include specific PMCF in the form of targeted clinical investigations, such as clinical studies, surveys, or registries.
What Does the December 2025 Proposed Amendment Change About PMCF?
Currently, most of the feedback from the European Commission (and the Notified Bodies audited by the Commission) have requested separate PMCF documentation in the form of PMCF plans and reports. This means that total submission documents under EU MDR at the very least may include PMCF plans, PMCF reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Technical Documents (and any related testing appendices associated with the technical file), Risk Management Files (and corresponding risk documentation such as risk assessment categorization tool), and depending on the device type and risk classification, a Summary of Safety and Clinical Performance, among others.
However, the new amendment from the European Commission proposes the following:
“Post-market clinical follow-up (PMCF) is an important requirement in Regulation (EU) 2017/746 to identify any safety issues that might appear during real world use of the device. To reduce the number of reports that manufacturers are required to draw up, manufacturers should be able to include the findings of the PMCF directly in the updated clinical evaluation report, without the need to draw up a separate PMCF evaluation report.”
How to Interpret the New PMCF Guidelines in Practice
Of note, the new amendment is not proposing to eliminate PMCF all together (though more on what this means for devices incorporated well-established technology (WET) later this month!). After all, the proposed amendment goes on to later confirm:
“The competent authority of the Member state may require the manufacturer to conduct defined post-market surveillance or PMCF activities within a specified period of time to generate additional clinical data to confirm the safety and performance of the device and to evaluate any undesirable side-effects and the acceptability of the benefit-risk ratio.
What we’re incorporating on a case-by-case basis at Minola Scientific is moving PMCF results typically included in a PMCF report to an appendix within the CER, especially in cases of low-risk, legacy devices not requiring specific, proactive PMCF activities in the form of PMCF studies. This process will allow for more streamlined interpretation and organization in the clinical evaluation.
