Spain · Spanish Agency of Medicines and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
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Spain limits the EU in-house exemption. Only hospitals may make medical devices for their own use, and not class IIb, class III or implantable devices. Health centers may make in-house in vitro diagnostics if their laboratories are accredited to ISO 15189. In both cases the center notifies the agency before it starts, may not subcontract the manufacturing, and may not sell or pass the products to others. A hospital or health center that makes and uses devices or in vitro diagnostics only within its own facility.
1. Prior communication to the agency; 2. Start of activity; 3. Later checks.
Outcome: The activity may start after the communication, subject to later checks and inspection.
Legal basis: Real Decreto 192/2023, article 9; Real Decreto 942/2025, article 9
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: Marketing registration of devices and IVDs in Spain (RECOPS), Prior operating licence for device manufacturers and importers, Custom-made devices: regional licence and national register. 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.