Spain · Spanish Agency of Medicines and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
8 requirements
Application fee
€100
2023 onward
On top of the EU rules, every economic operator that markets medical devices or in vitro diagnostics in Spain, other than custom-made devices, must first join the agency's marketing register and report each product with its UDI-DI, its Spanish labeling and instructions, and the start date. The entries are updated every year, or they are removed. Before marketing any non custom-made medical device, software device or in vitro diagnostic in Spain. Pharmacies and other points of sale only to the public are exempt.
The registration and communication of a device (per udi-di) is €100 for 2023 onward.
1. Sign up in the register; 2. Report each product; 3. Yearly update.
Outcome: Listing of the operator and its products in the national marketing register.
Legal basis: Real Decreto 192/2023, articles 5, 18 and 19; Real Decreto 942/2025, articles 5, 15 and 16; Real Decreto Legislativo 1/2015, article 123
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 |
|---|---|
| Registration and communication of a device (per UDI-DI)Product · 2023 onward · Discounts apply by number of UDI-DIs reported, from 8 percent for 2 to 9 up to 100 percent above 150. | €100 |
| Annual maintenance of product information in the marketing registerYearly · 2023 onward | €60 |
Other routes in Spain: Prior operating licence for device manufacturers and importers, Custom-made devices: regional licence and national register, In-house devices made by hospitals and health centers. 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.