Spain

Ministry of Health

Ministry of Health, Consumer Affairs and Social Welfare

Regulatory Authority

Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS)

Medical Device Regulation

EU MDR 2017/745

Official Language

Spanish

Classification

Class I, IIa, IIb and III

Registration Process

• Determine the device classification
• Appoint Authorized Representative and Notified Body
• Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
• For other classes, prepare a CE Technical File
• Obtain and register UDI in EUDAMED.
• Technical File should be audited by Notified Body.
• Once approved, prepare a Declaration of Conformity.
• The device can now be marketed in Spain