IVDR Support for In Vitro Diagnostic Manufacturers

We support you navigating In-Vitro Diagnostic Regulation (EU) 2017/746 with a practical, evidence-driven roadmap, from classification and technical documentation to performance evaluation and post-market follow-up.

Blood glucose meter, test tubes, and scientific lab equipment on a lab table with charts and monitors in the background.

Madrid-based CRO support for EU market access and evidence generation.

Request an IVDR Readiness Call
Send us your device summary

Build an IVDR-ready dossier that stands up to Notified Body expectations

IVDR requires stronger evidence, tighter traceability, and a structured approach to performance evaluation and post-market surveillance. We help you plan, generate, and compile the evidence needed to support conformity assessment and lifecycle compliance.

IVDR Services

    • Device classification support and rationale

    • Conformity assessment planning and submission roadmap

    • Gap assessment against IVDR requirements

    • Transition plan with priorities, timelines, and resource needs

    • Document structure and medical writing

    • Consistency checks across intended purpose, claims, risk, and evidence

    • Performance Evaluation Plan and Report (PEP/PER) development

    • Evidence mapping (scientific validity + analytical + clinical performance)

    • Clinical performance study execution and oversight

    • Analytical performance study

    • QMS alignment to IVDR needs (process integration, readiness)

    • Risk management file support aligned with ISO 14971 approaches

    • PMS planning and reporting

    • PMPF system setup and periodic reports (PSUR; SSP/SSP for IVDR)

    • Notified Body engagement strategy and response support

    • EUDAMED operator/device registration support where applicable

Typical deliverables

  • IVDR classification memo + conformity assessment plan

  • IVDD→IVDR transition plan (legacy devices)

  • Annex II/III Technical Documentation structure and content support

  • PEP + PER (performance evaluation plan/report)

  • PMS plan + PMPF plan/reports; PSUR/SSP

  • Notified Body interaction pack (readiness review + responses)

A person checks off items on an IVDR documentation checklist on a clipboard, surrounded by a binder labeled 'IVDR Compliance' and stacks of documents.

FAQs

  • Many IVDs require NB involvement under IVDR; only limited low-risk cases can be self-certified.

  • MDR governs medical devices; IVDR governs in vitro diagnostics and has specific performance evaluation and post-market performance requirements.

  • A structured report compiling scientific validity and analytical/clinical performance evidence to support IVDR compliance and conformity assessment.

  • Yes, gap assessment, reclassification considerations, and a transition plan to close documentation and evidence gaps.

  • Yes—planning and reporting support to maintain compliance across the device lifecycle.

Need an IVDR roadmap you can actually execute?

Share your device summary and current status. We will propose a practical next-step plan focused on regulatory readiness and evidence generation.

Contact our IVDR team