Spain, through the European Union route · Notified bodies · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
9 requirements
Application fee
-
Class IIb devices need a notified body audit of the quality management system and assessment of technical documentation. For most class IIb implantable devices, the technical documentation of every device is assessed. Class IIb active devices that administer or remove medicines go through an extra expert panel consultation. Class IIb medical devices, including many implants and software whose output may cause serious deterioration of health.
1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. Clinical evaluation consultation (active devices that administer or remove medicines) (21 days); 5. Certificate issued; 6. 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) 2017/745, Articles 52(4) and 54; Annexes IX to XI
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).
About 21 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
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 I sterile, measuring or reusable surgical devices, Class IIa 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet