Under the EU MDR, Post-Market Clinical Follow-up (PMCF) is no longer an occasional activity. It is a continuous, proactive obligation that requires structured, traceable clinical evidence across the entire device lifecycle.
Yet many manufacturers still rely on generic survey tools or marketing-style questionnaires to collect post-market data.
That approach may have worked pre-MDR.
Today, it creates risk.
Because PMCF data is not just “feedback.”
It is clinical evidence.
And clinical evidence must be designed like a study — not a form.
Surveys are now clinical investigations in disguise
MDCG 2020-6 clearly recognizes structured surveys as valid clinical evidence — but only when they are:
- methodologically justified
- protocol-driven
- statistically defensible
- monitored and traceable
- aligned with ISO 14155
In other words:
they must follow clinical trial principles.
This is where many software platforms fall short.
They provide:
- links
- dashboards
- forms
But they do not provide:
- clinical methodology
- regulatory justification
- defensible endpoints
- oversight
- inspection readiness
That gap becomes visible very quickly during Notified Body review.
Why 1MED is different
Unlike survey vendors, 1MED SA is a full-service CRO.
Clinical evidence is not an add-on service for us — it is our core business.
We design:
- Clinical investigations under ISO 14155
- PMCF plans
- Clinical Evaluation Reports
- PMS strategies
- Regulatory submissions
Every day.
So when we design a 1SURVEY+ program, we don’t start with:
“what questions do you want to ask?”
We start with:
“what evidence must you defend to your Notified Body?”
That difference changes everything.
Because it means:
- endpoints are clinically meaningful
- scales are validated
- sample sizes are justified
- protocols are inspection-ready
- outputs plug directly into CER/PSUR/SSCP
Not just spreadsheets.
