Competent authority
authority.competent-authority
Spanish Agency for Medicines and Medical Devices (AEMPS)
AEMPS · structured requirements
🇪🇸 Spain medical device regulatory data
Explore the medical device requirements currently available for Spain, organized by topic and linked to official sources.
6 facts5 dimensions5 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
Spanish Agency for Medicines and Medical Devices (AEMPS)
- SubmissionSurface
EUDAMED plus RECOPS national commercialization registration from 15 June 2026
- VerifiedHighlights
- AEMPS launched RECOPS on 15 June 2026 and ended new filings in the former CCPS/RPS routes except specified custom-made workflows.
- RECOPS receives Spanish-market commercialization information including labels and instructions.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
EUDAMED plus RECOPS national commercialization registration from 15 June 2026
- VerifiedHighlights
- AEMPS launched RECOPS on 15 June 2026 and ended new filings in the former CCPS/RPS routes except specified custom-made workflows.
- RECOPS receives Spanish-market commercialization information including labels and instructions.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-spain
- Target
geo:esp
- SourceApproval
EU CE under MDR/IVDR
- EdgeType
Single Market Validity
- MarketAccessStrength
direct
- RegulatoryLayer
Product Marketing
- SameDeviceRequired
Yes
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Türkiye CE under aligned MDR/IVDR — customs union free circulation
reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-spain
- Target
geo:esp
- SourceApproval
Türkiye CE under aligned MDR/IVDR
- EdgeType
Customs Union Free Circulation
- MarketAccessStrength
Direct With Local Obligations
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules
UDI, listing & traceability
Which UDI, device listing, database, and traceability duties apply?
Official UDI or listing surface
udi.official-listing-surface
- SubmissionSurface
EUDAMED plus RECOPS national commercialization registration from 15 June 2026
- VerifiedHighlights
- AEMPS launched RECOPS on 15 June 2026 and ended new filings in the former CCPS/RPS routes except specified custom-made workflows.
- RECOPS receives Spanish-market commercialization information including labels and instructions.
Need to apply Spain's requirements to a product?
Confirm the current AEMPS pathway, evidence, and local-role details for the actual device before filing.