European Union · Notified bodies · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
9 requirements
Application fee
€56,500
From 2025-01-01
Class C in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per generic device group. Self-tests and near-patient tests also get a technical documentation assessment. Companion diagnostics also need a medicines authority opinion. Class C IVDs.
The ema consultation on the suitability of a companion diagnostic is €56,500 for From 2025-01-01.
1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. Certificate issued; 5. Declaration of conformity, CE mark and registration.
Outcome: Notified body certificate, then the maker's EU declaration of conformity and CE marking.
Legal basis: Regulation (EU) 2017/746, Article 48(7); Annex IX
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| EMA consultation on the suitability of a companion diagnosticOther · From 2025-01-01 · SMEs with EMA SME status: 90% reduction; micro enterprises: 100% reduction. | €56,500 |
Other routes in European Union: Class I devices: maker's declaration of conformity, Class IIa devices: notified body conformity assessment, Class IIb devices: notified body conformity assessment, Class III devices: notified body conformity assessment, Medical device software: qualification, classification and conformity assessment, Class A IVDs: maker's declaration of conformity, Class B IVDs: notified body conformity assessment, Class D IVDs: notified body assessment with EU reference laboratory. See all routes on the European Union page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.