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
IVD Class A and MD Class I devices, including sterile and measuring devices, are registered via the RPS system; no official fees apply.
MD Class IIa, IIb and III devices, and in vitro diagnostic devices of Classes B, C and D, are registered via the CCPS.
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