Spain, through the European Union route · Notified bodies · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
9 requirements
Application fee
€114,700
From 2025-01-01
When a device includes a substance that would be a medicine on its own and supports the device's action, the device is class III. The notified body must ask a medicines authority, or the European Medicines Agency, for a scientific opinion on the substance. The authority gives its opinion within 210 days of receiving all documents. Devices incorporating, as an integral part, a substance that would be a medicinal product if used separately and that has an action ancillary to the device.
The ema consultation on an ancillary medicinal substance not previously evaluated is €114,700 for From 2025-01-01.
1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. Medicines authority scientific opinion (210 days); 5. Certificate issued; 6. Declaration of conformity, CE mark and registration.
Outcome: Notified body certificate that takes due account of the medicines authority's scientific opinion.
Legal basis: Regulation (EU) 2017/745, Article 52(9) and Annex IX, Section 5.2; Annex VIII, Rule 14
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 210 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| First review cycleregulation. Time for the medicines authority opinion after receipt of all documents. No legal time limit applies to the notified body review itself. Days shown are legal limits for specific consultations only. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| EMA consultation on an ancillary medicinal substance not previously evaluatedOther · From 2025-01-01 · SMEs with EMA SME status: 90% reduction; micro enterprises: 100% reduction. | €114,700 |
| EMA consultation on a device made of substances absorbed by or dispersed in the bodyOther · From 2025-01-01 · SMEs with EMA SME status: 90% reduction; micro enterprises: 100% reduction. | €86,100 |
| EMA consultation on an ancillary medicinal substance already evaluatedOther · From 2025-01-01 · SMEs with EMA SME status: 90% reduction; micro enterprises: 100% reduction. | €57,200 |
Other routes in Spain: Centralised marketing authorisation, new active substance, Class I devices: maker's declaration of conformity, 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, Integral drug-device combination authorised as a medicine. 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.