AEMPS
Agencia Española de Medicamentos y Productos Sanitarios
About
AEMPS is the Spanish competent authority responsible for ensuring the quality, safety, and efficacy of health products including medical devices, under the EU MDR regulatory framework.
Regulatory Details
Regulatory FrameworkEU MDR 2017/745 (Spanish implementation)
Device ClassificationClass I, Class IIa, Class IIb, Class III
Jurisdiction TypeNational
Country🇪🇸 Spain
StatusActive