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CE certification under MDR or IVDR: which stages lie ahead?

On the way to the notified body certificate and beyond it, classification, technical documentation, clinical evidence, QMS and post-market surveillance interlock. Here you see what happens in which stage; the details are on the linked expert page.

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Typical triggers

  • A new medical device or IVD is to receive the CE mark for the first time.
  • A legacy product has to move from the transitional provisions to full certification under MDR or IVDR.
  • The notified body has raised findings on the technical documentation or the clinical evidence.

Last updated: October 20, 2026

The path in 5 stages

  1. Stage 1

    Strategy and classification

    Class, conformity assessment route and notified body are fixed, and a gap analysis shows what is missing; for IVDs, the portfolio classification under Annex VIII of the IVDR is part of it. These decisions set which evidence the following stages have to deliver.

  2. Stage 2

    Build the technical documentation

    The evidence package the notified body reviews is in place: evidence for each general safety and performance requirement, UDI and registration in EUDAMED.

  3. Stage 3

    Demonstrate clinical evidence

    For medical devices, the clinical evaluation report is in place, linked with post-market surveillance. For IVDs, the performance evaluation under Annex XIII IVDR takes this place.

  4. Stage 4

    QMS under ISO 13485

    The QMS is built, rolled out and internally audited before the notified body assesses it as part of conformity assessment. After certification, the notified body audits at least once every 12 months.

  5. Stage 5

    On the market: surveillance

    Once the device is placed on the market, surveillance runs as a system, with the reports its class requires. What carries it is the data flow that brings complaints, vigilance reports and literature into risk management.

How we work with you

An Entourage project manager runs the plan, the schedule and escalation and reports to a steering committee.

Your point of contact in the project is the Entourage project manager.

How we work with you in the stages is set by the format: Strategy, Hybrid or Operational Consulting. See the formats →

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Track record

Projects that combined several stages

IVDR Certification for Class C and Class D IVDs: Complete Annex II/III Documentation

An IVD manufacturer faced critical IVDR deadlines for its Class D products, with limited internal capacity for the extensive regulatory, clinical and analytical requirements and insufficient evidence for the conformity assessment.

Learn more →

Frequently asked questions

Yes. The technical documentation is embedded in the QMS, though, and the notified body assesses both in the same conformity assessment. Both strands therefore need a joint plan.

Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.

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