NLGeneralInformation object

Yes

A list of International standards as well as European and Spanish legislation applicable to clinical trials with MDs is also available on the AEMPS website in section Investigaciones clínicas con productos sanitarios (in Spanish only).

Yes

The Spanish regulations and ordinances can be found on the official website of the State Agency Official Gazette within the Ministry of the Presidency BOE (Boletín Oficial del Estado).

Note: Currently, the Spanish Law regarding medical devices is not as fully characterized as it is regarding medicinal products.
In the event of doubts concerning the classification of the study, required documents or on the submission process itself, the Subdivision of Medical Devices at the Spanish Agency may be contacted for further clarifications:
Email: psinvclinic@agemed.es
FAX: +34 91 822 52 89