Post-Market Clinical Follow-up is no longer a technical-file formality. We design the PMCF Plan, choose the general and specific methods that actually fit your device, then run the activities and deliver a PMCF Evaluation Report that stands up to a reviewer's scrutiny.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to build and run their post-market clinical follow-up. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that knows exactly which gaps trigger a PMCF non-conformity. We write the PMCF Plan so its objectives, methods and indicators trace cleanly back to the Clinical Evaluation Report and the risk management file, and we run the activities with in-house CRAs rather than outsourced monitoring.
Under EU MDR 2017/745, post-market clinical follow-up is a continuous, proactive process, not a one-off document. Article 61(11) makes PMCF part of the clinical evaluation that has to be actively updated, and Annex XIV Part B sets out exactly what the PMCF Plan must specify. A plan that simply promises "literature monitoring" is the single most common reason a Notified Body issues a clinical deficiency.
The plan does not sit in isolation. Its findings flow into the Clinical Evaluation Report, the risk management file, the Periodic Safety Update Report and, for implantable and Class III devices, the SSCP. Get the loop right and every subsequent submission becomes easier.
These are the elements a reviewer checks off, one by one. We build each of them against your device, its risk class and the claims made in your Clinical Evaluation Report.
Confirm safety and performance across the device lifetime, detect emerging risks and side-effects, and check the benefit-risk ratio stays acceptable.
User and patient feedback, complaint and vigilance data, and systematic screening of scientific literature and relevant clinical data.
Proactively designed activities: PMCF surveys, registry-based studies and prospective observational PMCF studies to ISO 14155.
A justification of why each chosen method is appropriate, and why any option not selected was reasonably ruled out.
Explicit links to the relevant parts of the Clinical Evaluation Report and to the residual risks and claims being verified.
The methods and criteria used to evaluate the data, referenced to the current state of the art and applicable standards.
A detailed and adequately reasoned schedule for PMCF activities and for analysis and reporting, tied to device class.
The report that documents findings and feeds the CER, risk management, PSUR and SSCP, closing the loop.
Where PMCF is genuinely not appropriate, a defensible justification recorded in the Clinical Evaluation Report.
Most robust plans combine both. We select the lightest combination that still answers your open clinical questions, drawing on registries and real-world data where they fit. See our registry-based RWE approach.
From plan to report and back into the technical documentation, so your regulatory strategy stays coherent across every submission.
Read the CER, risk file and claims to pin down the open clinical questions.
Draft the Annex XIV Part B plan: objectives, methods, indicators and timeline.
Deploy surveys, registries or observational studies with in-house CRAs.
Analyse the data and document conclusions in the PMCFER.
Feed the CER, risk management, PSUR and SSCP, then re-plan.
Across therapeutic areas, from cardiovascular to neuromodulation devices.
RegenLab needed PMCF data for CE marking renewal without disrupting clinic workflows. Eclevar wrote a targeted PMCF Plan built on a registry study on the MILO Studio platform, capturing wound-healing trajectories and adverse-event tracking, delivered as an MDR-compliant PMCF Evaluation Report.
A PMCF Plan and multicentre study with retrospective and prospective chart data across French university hospitals (CHU Valenciennes, Nantes, Brest), covering carotid and femoral locations to 3 years post-surgery, meeting EU MDR requirements for CE certification.
The plan is only as strong as the technical documentation around it. We keep it aligned with your QMS and technical file.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, directly relevant to how a PMCF Plan is judged.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
The PMCF Plan is the document required by EU MDR 2017/745 Annex XIV Part B that defines how a manufacturer will proactively collect and appraise clinical data on a CE-marked device throughout its lifetime. It sets out the general and specific PMCF methods, the objectives, the indicators used to judge the benefit-risk profile, and a justified timeline, all referenced back to the Clinical Evaluation Report and the risk management file.
A PMCF Plan is part of the technical documentation for every device. Where a manufacturer concludes that PMCF is not appropriate, that conclusion must itself be justified and documented in the Clinical Evaluation Report. In practice Notified Bodies expect an active PMCF Plan for Class IIa, IIb and III devices and for implantables.
The PMCF Plan defines what data will be collected and how. The PMCF Evaluation Report (PMCFER) documents what those activities found and feeds the conclusions back into the Clinical Evaluation Report, the risk management file, the PSUR and, for implantable and Class III devices, the SSCP.
General methods gather existing clinical experience: user and patient feedback, complaint and vigilance data, screening of scientific literature and of relevant registers. Specific methods are proactively designed studies such as PMCF surveys, registry-based studies and prospective observational PMCF studies conducted to ISO 14155.
Yes. Eclevar designs the PMCF Plan, then runs the resulting activities with in-house CRAs across the UK, Germany, France and Sweden, capturing data on the MILO Studio platform and delivering a PMCF Evaluation Report that holds up to Notified Body scrutiny.
Talk to our team about your device class, open clinical questions and timeline, and the fastest compliant route to a Notified Body ready PMCF Plan and Evaluation Report.
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