A PMCF survey is a specific PMCF activity that collects structured clinical feedback from clinicians or patients on a CE-marked device. Done well, it is the fastest proportionate way to close a CER data gap; done badly, it is the first thing a Notified Body rejects. We design and run PMCF surveys, from simple satisfaction questionnaires to full Level 4 surveys with validated patient-reported outcomes, so the data actually confirms your benefit-risk profile.
PMCF surveys are one of the specific methods in a complete PMCF programme, alongside registry-based real-world evidence and the overall PMCF Plan.
Device leaders rely on Eclevar for PMCF planning, surveys, studies and registries. Read all client success stories.
Under EU MDR 2017/745, PMCF surveys are one of the "specific" PMCF methods listed in Annex XIV Part B and detailed in MDCG 2020-7. They gather predefined, structured information from a defined population of users or patients, on a defined sampling basis, to answer a specific clinical question left open by the clinical evaluation. A survey is not a mailing list or a marketing questionnaire: it is a controlled data-collection instrument with a protocol, endpoints and an analysis plan.
Every question maps to a residual risk or an open benefit-risk question in the Clinical Evaluation Report. If a survey item does not close a gap, it does not belong in the instrument.
The population, sample size and recruitment route are fixed in advance. Convenience samples and low response rates are the most common reason a survey is dismissed at review.
Outcomes are measured with defined scales and thresholds, so results can be appraised against the state of the art rather than read as opinion.
Survey findings are analysed in a Notified Body ready PMCF Evaluation Report that updates the CER, the PSUR and the risk management file.
Not every survey carries the same evidential weight. We classify PMCF surveys on four levels, and we match the level to what your device class and your CER gaps actually require. Higher-risk devices and equivalence-based CE marks almost always need Level 3–4.
Basic user or patient satisfaction and usability feedback. Useful signal, but rarely sufficient on its own for anything above low risk.
Structured clinical questions on performance and safety, with defined response scales and a fixed sampling frame.
Targeted clinical outcomes and adverse-event capture, powered for the specific question, with source verification where feasible.
A prospective survey built around validated patient-reported outcome instruments, with predefined statistics, representativeness checks and audit-ready documentation — evidence that stands next to a clinical investigation.
Level 4 surveys are an Eclevar specialty: when a full clinical investigation is disproportionate but a light questionnaire will not survive review, a Level 4 survey is often the proportionate route that a Notified Body accepts.
The single biggest lever on survey credibility is the instrument. A validated PRO (patient-reported outcome) has published evidence of reliability, validity and responsiveness in the relevant population; a home-made scale does not, and a reviewer will treat its results as unproven. Where a validated instrument exists for your indication, we use it; where none exists, we document the gap and justify the chosen measure.
Validated instruments produce stable, reproducible scores, so a change over time reflects the device, not noise in the questionnaire.
The instrument is proven to measure the clinical outcome it claims to — pain, function, quality of life — in your patient population.
A responsive PRO can pick up the size of clinical benefit your device is expected to deliver, so the survey can actually confirm benefit-risk.
Because validated PROs are used across the literature, your results can be appraised against the state of the art, which is exactly what a reviewer looks for.
Most rejected PMCF surveys fail for the same handful of reasons. We build every survey around the four that reviewers check first.
A predefined sampling frame and a target sample size justified against the device population — not "whoever replied". We plan recruitment across sites and geographies so the sample reflects real use.
A realistic response-rate plan with reminders and follow-up, plus explicit handling of non-response and selection bias, so the result is defensible.
Unambiguous, non-leading items mapped to endpoints, piloted before launch, with validated PROs wherever they exist.
A statistical analysis plan fixed before data collection, with thresholds tied to the state of the art, feeding a structured PMCF Evaluation Report.
A survey is the right tool for some questions and the wrong tool for others. Choosing correctly, and documenting why, is part of a defensible PMCF Plan.
When the question is confirmatory — satisfaction, usability, patient-reported function, real-world safety signals — a well-built survey (often Level 3–4) closes the gap proportionately.
For long-term implant survival or rare events, pair the survey with registry-based real-world evidence.
Novel indications, increased invasiveness or unresolved safety questions usually need a prospective PMCF investigation, not a survey alone.
Whichever route you choose, justify it in the PMCF Plan against MDCG 2020-7, so the method matches the risk.
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. »
Yes. Surveys are an explicitly recognised specific PMCF method under Annex XIV Part B and MDCG 2020-7, provided they are structured, sampled and analysed like a study rather than run as informal feedback.
A prospective survey built around validated PRO instruments with pre-specified statistics and representativeness controls — the highest-quality survey level, used when a full investigation is disproportionate but robust evidence is still required.
Usually for convenience sampling, low or unreported response rates, home-made scales, leading questions, or no pre-specified analysis. We build each survey to remove these failure modes.
Sometimes, for confirmatory questions on lower-risk or well-established devices. For novel, higher-risk or equivalence-based devices, a survey supports but does not replace a PMCF investigation.
One partner for the full survey toolkit: clinician and patient surveys, validated PROs, Level 4 studies and PMCF report writing, with in-house CRAs across European sites.
Talk to our team for a gap-mapped survey design, the right survey level for your device class, validated PROs where they exist, and a clear route to a Notified Body ready PMCF Evaluation Report.
Book a free PMCF survey consultation