European Union · Notified bodies · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
8 requirements
Application fee
-
Makers of class A in vitro diagnostic devices declare conformity themselves after preparing the technical documentation. Class A devices sold sterile need a notified body for the sterility aspects. Class A IVDs such as general laboratory products, instruments and specimen receptacles.
1. Classification and technical documentation; 2. EU declaration of conformity and CE mark.
Outcome: EU declaration of conformity and CE marking by the maker.
Legal basis: Regulation (EU) 2017/746, Article 48(10)
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 |
|---|---|
| No fees published. |
Other routes in European Union: Medical device software: qualification, classification and conformity assessment, Class B IVDs: notified body conformity assessment, Class C 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.