Spain, through the European Union route · Notified bodies · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
7 requirements
Application fee
-
Makers of class I medical devices declare conformity themselves after preparing the technical documentation. No notified body is involved, except for sterile, measuring and reusable surgical class I devices. The device is registered in the EU database before it is placed on the market. Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments.
1. Classification and technical documentation; 2. EU declaration of conformity and CE mark; 3. Registration in the EU database.
Outcome: EU declaration of conformity and CE marking by the maker.
Legal basis: Regulation (EU) 2017/745, Article 52(7)
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 Spain: Class I sterile, measuring or reusable surgical devices, 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, Device with an ancillary medicinal substance: medicines authority consultation, Class C IVDs: notified body conformity assessment. See all routes on the Spain 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.