The IVDR raised the clinical bar for in vitro diagnostics: most devices now need Notified Body review and a full performance evaluation. Eclevar plans and runs scientific validity, analytical and clinical performance studies under ISO 20916, with former Notified Body reviewers on the team.
Platinum Award 2026
Scientific validity, analytical and clinical performance in one connected performance evaluation, on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across cardiovascular, orthopaedics, wound care and more choose Eclevar. Read all client success stories.
An IVD CRO is a specialist partner that designs, runs and reports the performance studies an in vitro diagnostic manufacturer needs to CE mark a device under the IVDR (EU) 2017/746.
Unlike a therapeutic device CRO working to ISO 14155, or a pharma CRO working to ICH-GCP, an IVD CRO works to ISO 20916, the good clinical practice standard for IVD clinical performance studies. It builds the performance evaluation across its three pillars, scientific validity, analytical performance and clinical performance, and documents them in the performance evaluation report that a Notified Body assesses.
The IVDR reclassified most diagnostics into Classes A to D and pulled the large majority under Notified Body review, so legacy IVDD devices often need a substantial evidence upgrade to transition. An IVD CRO also runs post-market performance follow-up (PMPF) to keep that evidence current, connecting to our real world evidence and clinical data management capabilities.
Manufacturers typically engage an IVD CRO to build a defensible performance evaluation before submission, to close analytical or clinical performance gaps flagged by a Notified Body, or to transition a legacy IVDD product to the IVDR without losing the CE certificate.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopaedics and spine and also a former TÜV SÜD senior reviewer, lead a team that designs clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
An IVD run on a therapeutic-device or pharma template misreads the evidence the IVDR actually requires. The difference decides whether a Notified Body accepts your performance evaluation.
Every pillar of IVD evidence, run to ISO 20916 and assembled into a performance evaluation a Notified Body can accept.
Systematic evidence that the analyte is associated with the targeted clinical condition, the first pillar of the IVDR performance evaluation.
Sensitivity, specificity, precision, trueness, limits of detection and reference ranges, designed and executed to ISO 20916.
Studies establishing the correlation of results with clinical status in the intended population, with ethics and competent authority submissions where required.
The IVDR core clinical deliverable, written by our team and reviewed by former Notified Body assessors, tied to your clinical evaluation methodology.
Gap analysis of legacy evidence against the IVDR, classification and a roadmap to a compliant performance evaluation without losing the CE certificate.
PMPF and real world evidence that keep IVDR performance evidence current over the device life.
One accountable team covers every stage of the clinical investigation lifecycle, so nothing is lost between a protocol, a monitoring visit and a Notified Body submission.
Pre and post-market trials under ISO 14155, from feasibility and site selection and study initiation through multi-country ethics submissions and on-site and remote monitoring.
The clinical evaluation report under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house clinical data management and EDC: eCRF design, DMP and DVP, powered by MILO Studio, natively built for EU MDR.
Structured post-market clinical follow-up meeting MDCG 2020-7 Level 4 criteria, with validated questionnaires and MILO Studio capture.
National registry integration (NJR, EUDAMED) for long-term real world evidence and PMCF follow-up of implantable devices.
Regulatory affairs and clinical strategy for CE mark pathways and equivalence, backed by a quality management system certified to ISO 13485.
A manufacturer of a legacy IVDD assay faced reclassification under the IVDR and a performance evaluation that no longer met the new bar. Eclevar ran a gap analysis against the IVDR, confirmed the risk class, and rebuilt the evidence: a documented scientific validity dossier, targeted analytical performance work and a clinical performance study to ISO 20916 to close the remaining claims.
We wrote the performance evaluation report the way former Notified Body reviewers know assessors read it, managed specimens and data on MILO Studio, and designed the post-market performance follow-up to keep the file current after certification.
Outcome: a defensible IVDR performance evaluation and a clear route to keep the product on the EU market.
Former Notified Body reviewers from TÜV SÜD. We know what fails inspection and design programmes to avoid it.
Clinical ops, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC built natively for EU MDR, with Annex XIV mapping and AI eCRF generation.
Paris, London, Tokyo and Pune. In-house CRAs in seven countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every programme structured for TMF completeness and Notified Body inspection readiness.
A network of employed CRAs and project leads, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors.
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 high risk device 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. »
An IVD CRO designs, runs and reports the performance studies an in vitro diagnostic manufacturer needs to CE mark a device under the IVDR (EU) 2017/746. It works to ISO 20916 and builds the performance evaluation across scientific validity, analytical performance and clinical performance.
The IVDR is Regulation (EU) 2017/746. It replaces the IVDD, reclassifies most diagnostics into Classes A to D, brings the large majority under Notified Body review, and makes a full performance evaluation plus post-market performance follow-up mandatory.
The IVDR equivalent of the clinical evaluation report. It documents the three pillars of IVD evidence, scientific validity, analytical performance and clinical performance, and is the core clinical deliverable a Notified Body assesses for CE marking.
A study establishing that an IVD delivers results correlated with a clinical condition or physiological state in the intended population, following ISO 20916 good clinical practice, with ethics and competent authority approval where required.
The IVDD was largely self-certified; under the IVDR, risk class drives conformity, most devices need a Notified Body, and a full performance evaluation plus PMPF are mandatory. Many legacy IVDs need a substantial evidence upgrade to transition.
IVD evidence centres on scientific validity, analytical performance and clinical performance, under the IVDR and ISO 20916 rather than ISO 14155 or ICH-GCP. A specialist CRO with Notified Body experience avoids the classification and evidence gaps that stall an IVDR submission.
Talk to our specialists about your diagnostic, its risk class and the fastest compliant route to an IVDR performance evaluation.
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