Post-market clinical follow-up (PMCF) is the continuous, proactive collection of clinical data on your CE-marked device once it is on the market. Required by EU MDR 2017/745 Article 61(11) and Annex XIV Part B, it keeps your clinical evaluation live. We design the full programme, from general PMCF activities to PMCF surveys, observational PMCF and full Level 4 PMCF studies, so your benefit-risk profile stays confirmed and your CER data gaps stay closed.
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 PMCF planning, surveys, studies and registries. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that has assessed PMCF programmes from inside a Notified Body. We map every PMCF activity directly to your CER data gaps, because a PMCF Plan without direct gap-mapping to the clinical evaluation is a finding waiting to happen. That discipline runs from the first general PMCF activity through to a full Level 4 PMCF investigation.
Post-market clinical follow-up is defined by EU MDR 2017/745 Article 61(11) and detailed in Annex XIV Part B. It is a continuous, proactive process of gathering and appraising clinical data from the use of a device that already carries the CE mark. PMCF is the clinical arm of post-market surveillance: it does not wait for complaints, it generates new evidence.
The purpose is to keep the Clinical Evaluation Report alive throughout the device lifetime, to confirm safety and clinical performance, to detect emergent risks or off-label use, and to close any residual data gaps identified in the original clinical evaluation. Every PMCF activity feeds back into the clinical evaluation and into your wider EU MDR regulatory strategy.
PMCF runs for the whole life of the device. It is planned in advance, executed against defined objectives and re-evaluated on a schedule, so evidence keeps pace with real-world use rather than reacting to incidents after the fact.
Post-market surveillance (PMS) captures complaints, vigilance and trend data. PMCF is the specifically clinical part of that system: proactive, structured data collection that PMS reactive channels cannot replace on their own.
Annex XIV Part B and MDCG 2020-7 split PMCF activities into two families. General methods keep a broad watch on the device and its field; specific methods generate targeted new clinical data. A robust PMCF programme almost always combines both, with each activity mapped to a named CER data gap.
General PMCF activities monitor the device and its clinical environment continuously and at low incremental cost. On their own they are rarely sufficient for higher-risk devices, but they are a mandatory backbone for every class.
Systematic, documented monitoring of published literature, guidelines and state-of-the-art on the device, equivalent devices and the clinical condition, feeding the ongoing clinical evaluation.
Structured review of complaints, vigilance reports, field safety corrective actions and trend reporting, analysed for clinical signals rather than treated as a passive log.
Feedback gathered from clinicians and patients in routine practice, including patient-reported outcomes, captured in a structured, traceable way.
Lightweight PMCF surveys of users and patients can serve as a general activity, sampling real-world experience and satisfaction to flag areas that may need a specific study.
Specific PMCF activities are designed to answer a defined clinical question and generate new data on your device. These are the methods that close CER gaps a literature review cannot, and they are where most PMCF investment goes for Class IIb and Class III devices.
Structured PMCF surveys using validated, disease-specific instruments completed by clinicians or patients at sites with confirmed device use, governed by a formal PMCF protocol with ethics oversight. Milo Studio powers Annex XIV-mapped data capture. For many Class IIa and IIb devices a high-quality PMCF survey is a proportionate specific method.
Prospective, multi-centre observational PMCF that collects real-world evidence beyond survey capability, without the intervention of a pivotal trial, under ISO 14155:2026. Delivered across France, Germany, the UK, Italy and Spain with in-house CRA monitoring. See our real-world evidence and registry PMCF capability.
Participation in device registries such as NJR (UK), EPRD (Germany) and Swespine (Sweden and Denmark), with UDI linkage, EUDAMED registration and Milo Studio reconciliation. Registry participation is designed in at protocol stage, not bolted on post-market.
A full PMCF clinical investigation under ISO 14155:2026 where lower-evidence methods cannot close the gap, typically for Class III devices, implantables or novel mechanisms of action. This is the highest-evidence specific method, run with on-site and remote clinical monitoring and robust feasibility and site selection.
MDCG 2020-7, the guidance on the PMCF Plan template, sets out a hierarchy of PMCF method categories by the strength of clinical evidence they produce. In common industry shorthand these run from lower-evidence activities such as literature review and analysis of routine data, through PMCF surveys, up to prospective studies. A Level 4 PMCF is the top of that hierarchy: a full, prospective PMCF clinical investigation or study conducted specifically to generate new clinical data on the device. A Level 4 PMCF is what higher-risk devices, Class III and implantables usually need when surveys and registries cannot close the CER data gaps on their own. Selecting the right level, and being able to justify it to a Notified Body, is the core of a defensible PMCF Plan.
How much PMCF, and which methods, scale with device risk class. The table below summarises how PMCF for a medical device is typically structured under EU MDR and MDCG 2020-7.
| Device class | PMCF activity requirement | Reporting | Key reference | Long-term follow-up |
|---|---|---|---|---|
| Class I | PMCF if justified by the PMS plan; often literature monitoring and complaint analysis. | PMSR, as needed | EU MDR Art. 83; MDCG 2020-7 | Not typically required (non-sterile, non-measuring). |
| Class IIa | Active PMCF required; PMCF surveys typically sufficient if validated. | PMSR, periodic | Annex XIV Part B; MDCG 2020-7 | 2 to 5 years for implantable Class IIa. |
| Class IIb | Robust programme; surveys, observational PMCF or registry participation with documented gap-mapping. | PSUR, every 2 years | Annex XIV Part B; EU MDR Art. 86 | 5+ years for implantables; registry integration expected. |
| Class III | Comprehensive programme; full PMCF investigations (Level 4), registry linkage or both; highest NB scrutiny. | PSUR, annually | EU MDR Art. 61; Annex XIV Parts A & B | Long-term architecture; EUDAMED reporting. |
| Class III AIMD | Maximum scrutiny; long-term architecture from protocol design; EUDAMED registration and annual PSUR. | PSUR, annually | EU MDR Art. 32; MDCG 2021-3 | Follow-up out to the implant lifetime; patient contact at every visit window. |
PMCF is only valuable when its findings flow into the documents a Notified Body actually reviews. The PMCF Evaluation Report is an input, not an endpoint: it updates the clinical evaluation, the periodic safety reporting, the public performance summary and the risk management file.
PMCF findings feed the ongoing clinical evaluation under Article 61. Any result that changes the benefit-risk conclusion triggers a CER update. Read our Clinical Evaluation Report service.
For Class IIa and above, the PMCF Evaluation Report is a direct input to the PSUR under Article 86, summarising the clinical data collected and the conclusions drawn in the reporting period.
For implantable and Class III devices, the Summary of Safety and Clinical Performance under Article 32 must reflect current PMCF findings, keeping the public-facing performance statement aligned with the latest evidence.
New PMCF data flows back into the risk management file, re-testing residual risk assumptions and the benefit-risk determination as real-world evidence accumulates.
Identify the residual data gaps and open questions in the clinical evaluation that PMCF must close.
Run the chosen activities: PMCF surveys, observational PMCF, registries or a Level 4 investigation.
Analyse and appraise the data in a Notified Body ready PMCF Evaluation Report.
Update the CER, PSUR, SSCP and risk management, then re-enter the cycle.
The right PMCF method mix depends on the specialty. We run PMCF surveys, observational PMCF and full studies across the areas where evidence expectations are highest.
VARC-3 endpoints for TAVI, structural heart, guidewires and drug-coated balloons, with the transition from investigator-initiated studies to formal PMCF handled across France, the UK, Germany and Italy. See our cardiovascular clinical strategy.
Heterogeneous populations (DFU, pressure injuries, surgical wounds) under EWMA guidance, with validated instruments (PUSH, BWAT, Wound-QoL). PMCF surveys and observational programmes across France, the UK and Germany.
Registry-based PMCF is no longer optional for Class IIb and III: NJR, EPRD and Swespine with registry linkage, radiographic measurement charters and long-term architectures.
SCS, DBS, cochlear and peripheral nerve stimulation are Class III active implantables triggering long-term follow-up, with annual EUDAMED reporting and PROMs at every visit. Milo Studio automates visit windows and missed-visit escalation.
Protocols, data management and reporting are executed under an ISO 13485 quality management system, so your PMCF evidence is auditable end to end, from the Milo Studio data trail to the signed PMCF Evaluation Report.
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, relevant to any PMCF programme.
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. »
PMCF, or post-market clinical follow-up, is a continuous and proactive process of collecting and evaluating clinical data on a CE-marked medical device once it is in routine use. It is required by EU MDR 2017/745 Article 61(11) and Annex XIV Part B, and it feeds the ongoing clinical evaluation to confirm the benefit-risk profile and safety of the device throughout its lifetime.
PMS is the overarching system that collects all post-market data on a device, including complaints, vigilance and trend reporting. PMCF is the specifically clinical part of PMS: a proactive, structured programme that generates new clinical evidence. PMCF findings feed back into PMS, the PSUR and the Clinical Evaluation Report, and cannot be replaced by reactive vigilance alone.
PMCF surveys are a structured method of collecting clinical and patient-reported data on a device in real-world use, usually through validated, disease-specific questionnaires completed by clinicians or patients at sites with confirmed device use. Well-designed PMCF surveys are governed by a formal PMCF protocol with ethics oversight and are a recognised specific PMCF method under MDCG 2020-7. For many Class IIa and IIb devices, high-quality PMCF surveys are a proportionate way to generate new clinical evidence.
A Level 4 PMCF refers to the highest-evidence category in the MDCG 2020-7 hierarchy of PMCF methods: a full, prospective PMCF clinical investigation or study conducted specifically to generate new clinical data on the device, as opposed to lower levels such as literature review or survey-based follow-up. Level 4 PMCF is typically used for higher-risk devices, Class III and implantable devices, or where the CER data gaps cannot be closed by surveys or registries alone.
The PMCF Plan is the document required by Annex XIV Part B that specifies the methods, objectives, timelines and CER data gaps the manufacturer will address. A PMCF study is one of the activities carried out under that plan, such as a survey, an observational study, registry participation or a full clinical investigation. The plan defines what will be done and why; the study is the evidence-generating activity that delivers it, with the PMCF Evaluation Report summarising the results.
The PMCF Evaluation Report is a direct input to the Periodic Safety Update Report (PSUR) under Article 86 and to the update of the Clinical Evaluation Report under Article 61. For implantable and Class III devices, the Summary of Safety and Clinical Performance (SSCP) under Article 32 must also reflect current PMCF findings, so any change in the benefit-risk conclusion flows through into the PSUR, the SSCP and the device risk management file.
Talk to our team for a gap-mapped PMCF Plan, the right mix of general and specific PMCF activities for your device class, and a clear route to a Notified Body ready PMCF Evaluation Report.
Book a free PMCF consultation