Your legacy IVD file has to survive Notified Body review, and the Article 110 clock is running. Eclevar runs end-to-end IVDD-to-IVDR transitions for high-risk Class C and D in vitro diagnostics, Performance Evaluation Report to submission, with in-house teams and former Notified Body reviewers who know exactly what makes a dossier fail.
Former NB reviewers · IVDR native
Your Performance Evaluation Report is written and challenged by people who assessed these dossiers at a Notified Body, 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
From Japanese and Indian sponsors entering the EU to European regenerative-medicine leaders, our teams carry files through Notified Body review. Read all client success stories.
The IVDR transition is the move of in vitro diagnostics from the old IVD Directive 98/79/EC to the In Vitro Diagnostic Regulation (EU) 2017/746, which introduced risk-based classes A to D, mandatory Notified Body conformity assessment for higher-risk devices, and a far more demanding clinical evidence standard.
Under the IVDD, most diagnostics reached the market by self-declaration. Under the IVDR, the majority of devices are up-classified and must now pass a Notified Body, with clinical evidence built as a structured Performance Evaluation Report under Annex XIII rather than a light literature file. This is the same evidence-first shift EU MDR brought to medical devices, applied to diagnostics.
The transition runs on staggered legal deadlines set by Article 110, as amended by Regulation (EU) 2024/1860. Legacy Class D devices must be IVDR-certified by 31 December 2027 and Class C by 31 December 2028, but only if each manufacturer met the class-specific gates: a formal Notified Body application, a signed written agreement four months later, and an Article 10(8) quality management system. Miss a gate and the transition benefit is lost entirely.
With Notified Body review running 18 to 24 months and capacity tight, starting late is the single biggest risk to market access. Eclevar delivers the transition as one connected service, from gap analysis to submission, feeding the IVD clinical research and the post-market performance follow-up that keep an IVDR certificate valid.
Eclevar's model brings the reviewer's perspective inside the CRO, closing the gap between what manufacturers submit and what assessors expect from a Class C or D dossier. Dr Mark DaCosta, COO and former TÜV SÜD clinical reviewer, leads a team that knows what makes a Performance Evaluation Report defensible, where Notified Body queries originate, and how to structure an IVDR file so it survives scrutiny the first time, from the first draft of the Annex XIII argument.
Generic CROs adapt EU MDR processes to IVDs. We built our IVDR service from the inside out, by the people who reviewed these dossiers at Notified Bodies.
Performance evaluation under IVDR Annex XIII is not a literature review. It is a structured, three-part clinical argument, backed by PMPF and a submission-ready Technical Documentation package, that must hold under Notified Body scrutiny.
Audit the existing dossier against IVDR Annex XIII and Notified Body expectations, delivering a written gap report and remediation roadmap sequenced to the Article 110 gates.
Establishes the association between the analyte and the clinical condition: a systematic literature review, GRADE-level appraisal and a documented state-of-the-art summary a Notified Body will accept.
Demonstrates precision, accuracy, linearity, interference, carry-over and stability, run on Milo Studio EDC and, for Class D, defensible against EURL batch-verification.
Confirms the clinical claim in the intended population with prospective, retrospective or banked samples, design and site activation sequenced to meet the transition gate timeline.
Ongoing performance monitoring after certification: a PMPF plan, evaluation report and vigilance integration, structured for NB surveillance expectations from day one.
The full Technical Documentation under Annexes II and III, NB query management and gate sequencing, backed by our ISO 13485 quality system.
One accountable team covers every stage of the legacy transition, so nothing is lost between a gap analysis, a performance study and a Notified Body submission.
End-to-end transition for the highest-risk legacy in vitro diagnostics, from gap analysis to Notified Body certification, sequenced against the Article 110 gates as part of our IVD clinical research CRO.
SVR, analytical and clinical performance and PMPF, written as one structured argument under Annex XIII Parts A and B, in the same discipline as our clinical evaluation reports for devices.
CPS protocol, site selection and activation, data capture on Milo EDC, biostatistics and the Clinical Performance Report.
Post-Market Performance Follow-up plans, evaluation reports and vigilance links, extended with real world evidence for long-term IVDR surveillance.
EU reference laboratory batch-verification sequences anticipated by design, so the highest-risk Class D files are planned around EURL timing rather than surprised by it.
Regulatory affairs and conformity strategy plus an Article 10(8) quality management system certified to ISO 13485, aligned to the transition gates.
A manufacturer of a high-risk infectious-disease assay held a legacy Class D file built for the IVDD and unfit for IVDR review. Eclevar rebuilt the Performance Evaluation Report against Annex XIII Part A, then designed the analytical and clinical performance studies with EU reference laboratory batch-verification anticipated from day one, capturing every data point on Milo EDC.
The PMPF plan and vigilance link were structured so the Class D file would withstand Notified Body scrutiny, and the whole programme was sequenced against the application and written-agreement gates to protect the Article 110 transition benefit.
Outcome: a Notified Body-ready dossier with a documented gap analysis and remediation roadmap, instead of a legacy file heading for rejection. Figures illustrative of this study type, not specific client data.
Former Notified Body reviewers from TÜV SÜD. We know what fails an IVDR assessment and build the file to avoid it.
Performance evaluation, clinical operations and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC with Annex XIII data dictionaries pre-built and inspection-ready for legacy transitions.
Application, written agreement and QMS milestones tracked from day one, so the Article 110 transition benefit is protected.
Platinum Award winner, xShare & EUCROF 2026, recognised for clinical innovation and evidence planning.
ISO 13485 certified. Every dossier structured for Technical Documentation completeness and Notified Body review.
A network of employed clinical and regulatory teams, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors, with performance studies activated at European reference centres.
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, and a useful lens on the evidence-first direction the IVDR now brings to diagnostics.
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. »
Under Article 110 of the IVDR as amended by Regulation (EU) 2024/1860, legacy Class D IVDs must be IVDR-certified by 31 December 2027 and Class C by 31 December 2028, provided the manufacturer met the class-specific milestones: a formal Notified Body application (Class D by 26 May 2025, Class C by 26 May 2026) and a signed written agreement four months later, with an Article 10(8) QMS in place by 26 May 2025. Missing a gate removes the transition benefit.
A PER under IVDR Annex XIII consolidates scientific validity, analytical performance and clinical performance evidence, supported by a Performance Evaluation Plan (PEP) and maintained through Post-Market Performance Follow-up (PMPF). It is a structured three-part clinical argument, not a literature review, and must be written the way a Notified Body reviewer actually evaluates it.
Class D covers the highest-risk IVDs, those used for blood screening and confirmatory testing for life-threatening infectious diseases such as HIV, HCV, HBV and HTLV, and certain rare diseases. They require mandatory EU reference laboratory (EURL) batch verification in addition to Notified Body certification. Class C covers high-risk devices such as companion diagnostics, oncology markers, cardiac biomarkers and sepsis assays, requiring a full PER and Notified Body conformity assessment but not EURL batch verification.
Yes. We deliver the full Technical Documentation package aligned to IVDR Annexes II and III, manage Notified Body queries, and have former Notified Body reviewers on the core team. We also manage the gate milestones, application and written agreement, to protect the transition benefit throughout the programme.
Yes, when properly documented. The sample chain of custody, biobank consent and pseudonymisation must comply with applicable national law and GDPR. We design clinical performance study protocols that maximise the use of banked samples to keep timelines realistic against the transition gate, while ensuring the dataset will withstand Notified Body scrutiny.
Generic CROs adapt EU MDR templates to diagnostics and miss the Annex XIII specifics: scientific validity, analytical and clinical performance, EURL sequencing for Class D and PMPF as a Notified Body argument. A specialist IVD clinical research CRO with former Notified Body reviewers builds the Performance Evaluation Report the way assessors read it, from day one.
Spend 30 minutes with a former Notified Body reviewer. Leave the call with a costed transition plan and a clear answer on whether your Class C or D file makes the deadline.
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