IVDR · Performance · Evidence
Eclevar delivers this as part of its full IVD clinical research CRO service under the IVDR (EU) 2017/746, from scientific validity to clinical performance.
IVD clinical evidence, under the IVDR.
The IVDR reclassified most diagnostics and made a Performance Evaluation Report mandatory. Understand the three pillars of performance and the evidence a Notified Body now expects.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Diagnostics evidence, from people who assess it.
The IVDR raised the bar for most diagnostics. Our teams build the performance evidence the way a Notified Body reads it.
Dr Mark DaCosta
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
in LinkedIn
Sébastien Meier
Endpoints, statistics and RWE; architect of the MILO EDC, 21 CFR Part 11 and real-time dashboards.
Awards, 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 framework
Three pillars of performance.
Under the IVDR 2017/746, clinical evidence for a diagnostic is built on three interlocking pillars, all captured in the Performance Evaluation Report (PER).
01
The classification shift
The IVDR replaced the IVDD and moved from a list-based to a risk-based classification (Class A to D). The result: the large majority of diagnostics now require Notified Body involvement, where under the IVDD most were self-certified. That single change reshaped the evidence burden.
02
Scientific validity
The association of the analyte with a clinical condition or physiological state, demonstrated from the literature, expert consensus and, where relevant, proof-of-concept studies. It answers: is measuring this analyte meaningful at all?
03
Analytical performance
The ability of the device to correctly detect or measure the analyte: sensitivity, specificity, accuracy, precision, limits of detection and quantification, and interference. It answers: does the assay measure what it claims, reliably?
04
Clinical performance & the PER
The ability of the device to yield results correlated with the clinical condition, expressed through diagnostic sensitivity and specificity and predictive values. All three pillars are drawn together in the Performance Evaluation Report, updated across the device lifetime through post-market performance follow-up (PMPF).
What the PER must show
- Scientific validity of the analyte-condition link
- Analytical performance against defined acceptance criteria
- Clinical performance with diagnostic sensitivity and specificity
- A PMPF plan to maintain the evidence
IVDR at a glance
The evidence a diagnostic now needs.
Talk to a specialist
Is your diagnostic’s performance evidence IVDR-ready?
Book a free scoping call. We build the Performance Evaluation Report and the studies behind it to the standard a Notified Body expects.
Book a free scoping callUnder the IVDR, self-certification is no longer the plan.
An expert read tells you your IVDR class, the performance studies you need, and how to structure a Performance Evaluation Report that clears review.
Book a free scoping callQuestions we hear first