EU MDR · PMCF · PROs
Why validated PROs anchor a credible PMCF survey.
A PMCF survey built on an ad-hoc questionnaire carries little regulatory weight. A validated PRO does. Here is why, and how to choose the right one.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Surveys that carry regulatory weight.
A survey is only evidence if the instrument is validated. Our biometry team selects and deploys PROs that reviewers accept.
Sébastien Meier
Endpoints, statistics and RWE; architect of the MILO EDC, 21 CFR Part 11 and real-time dashboards.
Pierre-Marie Boutanquoi
CERs and PMCF plans under EU MDR and MEDDEV 2.7/1 Rev 4, and Notified Body deficiency response.
in LinkedInAwards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The case
Why the instrument matters more than the questions.
Notified Bodies increasingly expect patient-reported outcomes in PMCF. But a home-made questionnaire is not evidence; a validated PRO is.
01
What validation actually means
A validated PRO has demonstrated psychometric properties: reliability (consistent results), validity (it measures what it claims), and responsiveness (it detects real change). Those properties are what turn survey answers into defensible clinical evidence.
02
Why Notified Bodies weigh them
Under EU MDR, PMCF must proactively confirm safety and performance. Reviewers accept validated PROs because their measurement properties are known and published, whereas an ad-hoc questionnaire has unknown reliability and cannot support a benefit claim.
Validated beats ad-hoc because
- Reliability and validity are established and published
- Results are comparable across studies and over time
- The instrument detects genuine change, not noise
- A reviewer can trust the numbers behind your claim
03
Choosing the right instrument
The right PRO depends on the device, the indication and the claim: FACE-Q and GAIS for aesthetics, EQ-5D-5L for quality of life, condition-specific instruments for orthopaedics, wound care and continence. Match the instrument to the endpoint, not the other way around. See our The FACE-Q survey guide for an aesthetics example.
04
Deploying them well
Even a validated PRO fails if completion is low or translations are not validated. We deploy PROs on an ISO 14155- and GDPR-compliant ePRO platform, with validated translations and reminders, so the data is both credible and complete.
PROs at a glance
Measurement you can defend.
Talk to a specialist
Is your PMCF survey built on a validated instrument?
Book a free scoping call. We select the right validated PRO for your device and claim, and deploy it so the data holds up.
Book a free scoping callAn unvalidated questionnaire is not clinical evidence.
An expert read selects the validated PRO that fits your device and claim, and designs the PMCF survey so a Notified Body accepts the result.
Book a free scoping callQuestions we hear first