Medical Device Registration in
Spain
Ministry of Health
Ministry of Health, Consumer Affairs and Social Welfare
Regulatory Authority
Medical Device Regulation
EU MDR 2017/745
Official Language
Spanish
Classification
Class I, IIa, IIb and III
Medical Device Registration in Spain
- 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
Documents Required
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Label, IFU and User Manual
Post-market Requirements
Serious public health threats – 2 day
Death or serious health deterioration – 10 days
Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
- No defined registration timeline.
- Import License is issued in 30 days
Authorized Representative
Yes
License Validity
5 years
Special Notes
Documents and IFUs should be in Spanish