Spain, through the European Union route · Notified bodies · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
-
Class I devices that are sterile, have a measuring function or are reusable surgical instruments need limited notified body involvement. The notified body checks only sterility, metrology or reuse aspects, under Annex IX Chapters I and III or Annex XI Part A. Class Is, Im and Ir devices.
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 for the limited aspects, then the maker's EU declaration of conformity and CE marking.
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 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, Device with an ancillary medicinal substance: medicines authority consultation. 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.