Conformity assessment is how a manufacturer demonstrates that a device meets the IVDR before applying the CE mark. For all but non-sterile Class A devices, it involves a notified body: an independent organization designated by an EU member state.
Routes by class
| Class | Typical route |
|---|---|
| A (non-sterile) | Manufacturer self-declares conformity; no notified body |
| A (sterile) | Notified body review limited to sterility aspects |
| B | Notified body audits the quality system and reviews technical documentation for representative devices |
| C | Notified body audits the quality system and reviews technical documentation for representative devices of each generic group; companion diagnostics are reviewed individually with consultation of the medicines regulator |
| D | Notified body audits the quality system and reviews the technical documentation of each device; EU reference laboratory verification where designated, expert panel consultation in some cases, and batch verification |
Self-tests and near-patient tests receive an additional design review. Alternative routes combine EU type-examination (Annex X) with production quality assurance (Annex XI).
Working with a notified body
- Capacity is limited: only a small number of notified bodies are designated under the IVDR, so start conversations early
- Timelines: from application to certificate commonly takes a year or more
- Structured dialogue: notified bodies may answer regulatory and procedural questions before and during assessment
- Certificates: valid for up to five years, with annual surveillance and unannounced audits
- Changes: significant changes to a certified device or the quality system must be notified and may require approval
Preparing for a smooth review
- Confirm classification and intended purpose before applying
- Choose a notified body with experience in your technology
- Submit complete, well-organized technical documentation
- Make the performance evaluation easy to follow, with clear links to the general safety and performance requirements
- Respond to questions quickly and completely
- Plan product launches around realistic certification timelines
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
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For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.