ES(AEMPS) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Spanish Regulatory Authority

Competent authority: Spanish Agency for Medicines and Health Products (AEMPS – Agencia Española de Medicamentos y Productos Sanitarios)

Link to the regulatory authority’s official website: https://www.aemps.gob.es

Regulatory Framework

EU Regulations: Medical Device Regulation (EU) 2017/745 (MDR); Medical Device Regulation (EU) 2017/746 (IVDR)

Spanish National Regulations: Royal Decree 192/2023 (MDR); Royal Decree 942/2025 (IVDR)

Risk classification of medical devices and IVD products

In line with the EU MDR and IVDR.

Authorised Representative

EU Authorised Representative: Non-EU companies must appoint an EU Authorised Representative (AR), who must have a physical presence within the EU and assume legal liability.

It is not necessary to appoint a local representative in Spain; however, a locally registered agent in Spain must be selected to complete the registration in the Spanish National Register.

Essential Requirements for Market Access

Medical devices may only be sold in Spain in compliance with the regulations once they have been registered with the Spanish national commercial register (Registro de comercialización).

Documents required for registration

Original EU registration documents; Spanish-language version of the labelling

Registration Language

English alone is not permitted. All materials intended for users and patients must be available in Spanish.

Registration Process, Timeline and Official Fees

Registration System：According to announcements issued by the Spanish Agency of Medicines and Medical Devices (AEMPS), the legacy CCPS system (for Class IIa and higher devices) and RPS system (for Class I devices) were switched to read-only mode on 28 May 2026 and are only accessible for historical data enquiries. The new RECOPS system officially launched on 15 June 2026, dedicated to the market registration of non-custom general medical devices and in vitro diagnostic devices (IVDs).

Registration Process：All products must first complete notification in the EU EUDAMED database, followed by local Spanish market registration via the RECOPS system within six months.

Registration Timeline：Processing durations under the legacy systems (2–4 weeks) are for reference only. As a newly launched platform, the RECOPS system is expected to take 1–2 months for registration review.

Official Fees

The RECOPS system imposes market registration fees on devices of all risk classes (Class I, IIa, IIb and III).
An annual maintenance fee equivalent to 60% of the initial registration fee shall be payable post-market launch.
Fees are calculated based on the number of UDI-DIs, with an estimated unit price of EUR 99.71; tiered volume discounts apply according to the total number of declared UDI-DIs.

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