Post-market clinical follow-up is no longer a nice-to-have. Understand your exact obligations under Annex XIV Part B, explore the PMCF methodologies, and keep your CE mark and technical documentation compliant.
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 for proactive PMCF that keeps their technical documentation compliant. Read all client success stories.
Under EU MDR, a PMCF Plan is judged on whether every activity maps back to the gaps in your Clinical Evaluation Report. COO Dr Mark DaCosta, a former TÜV SÜD reviewer, leads a team that has assessed these files from inside a Notified Body, so your plan is built to answer the questions before they are asked.
Annex XIV Part B explicitly defines PMCF as a continuous, proactive process that updates the Clinical Evaluation Report. It is not something you do once, and it cannot be replaced by reactive complaint handling.
"Under EU MDR, absence of evidence is not evidence of safety. If you are not proactively collecting clinical data on your device in the real world, your technical documentation is considered fundamentally non-compliant."
The reviewer's default position| Device class | PMCF obligation and expectation | Typical evidence strategy |
|---|---|---|
| Class I & IIa | PMCF required. A manufacturer may justify not running a new study if PMS and literature data are robust and well documented. | PMCF surveys (physician and patient PROMs), literature reviews, structured PMS. |
| Class IIb | A proactive PMCF study is generally expected. Any justification not to run one, such as well-established technology, must be documented. | Structured surveys, retrospective EHR data, lightweight observational studies. |
| Class III & implantables | Strictly mandatory. Absence of a proactive programme can mean certification suspension. | Prospective observational studies, European registries, longitudinal PROMs. |
Not every programme needs a clinical investigation. The right activity depends on your device class, indication and the unresolved data gaps in your CER.
The most cost-effective option for Class I to IIb: physician and patient surveys with validated instruments and genuine regulatory weight.
Discover PMCF surveys ›Prospective PMCF using the MILO EDC platform to capture real-world safety and performance data across European sites.
Explore observational PMCF ›Extract real-world evidence from national registries such as the NJR, EPRD and Swespine, mapped to your regulatory claims.
Read the registry guide ›Strategic documentation drafted by a team that includes a former Notified Body reviewer, mapped directly to your CER data gaps.
Master the PMCF Plan ›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, the same expectations your PMCF has to satisfy.
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, combining Eclevar's ISO 14155 clinical expertise with the Milo Studio platform.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »Antoine Turzi, CEO, RegenLab
Passive, reactive surveillance is not sufficient under EU MDR. PMCF is a continuous, proactive process required by Annex XIV Part B to confirm a device's safety and performance throughout its lifetime, identify emergent risks and keep the benefit-risk ratio acceptable, feeding directly into the Clinical Evaluation Report.
For low-risk devices (Class I and IIa), a manufacturer may justify not running a new study if existing PMS and literature data are robust, but that justification must be heavily documented. Class IIb and Class III devices generally require proactive PMCF studies.
Physician and patient surveys with validated PROMs, prospective observational studies, and real-world evidence extracted from national registries such as the NJR, EPRD and Swespine, all governed by a formal PMCF plan.
For Class III and implantable devices, PMCF is strictly mandatory. Absence of a proactive PMCF programme means the technical documentation is considered fundamentally non-compliant, which can lead to certification suspension.
Ideally, people who have assessed these files from the other side. Eclevar's PMCF plans are drafted by a team that includes a former Notified Body reviewer, so each activity is mapped to the CER data gaps a reviewer will look for.
Tell us about your device and its class. We will map your Annex XIV Part B obligations to the right activity mix and give you a clear, costed PMCF plan.
Book a free strategy call