Things You Should Know Before Registering Your Medical Devices in Spain

Spain Medical Device Regulations 2026: EU MDR and AEMPS Requirements

Manufacturers planning to commercialize medical devices in Spain in 2026 must comply with the EU Medical Device Regulation (EU MDR 2017/745), mandatory EUDAMED registration requirements, and oversight from Spain’s national competent authority.

Spain is one of the largest healthcare markets in Europe. However, regulatory expectations under MDR are significantly more stringent than under the former Directives, particularly in clinical evidence, post market surveillance, and data transparency.

Who Regulates Medical Devices in Spain?

Medical devices in Spain are regulated by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) – the Spanish Agency for Medicines and Medical Devices.

AEMPS is responsible for:

• Market surveillance and inspections
• Vigilance and incident reporting oversight
• Clinical investigation approvals
• Supervision of economic operators
• Enforcement of EU MDR requirements at the national level

While MDR harmonizes rules across the EU, AEMPS plays a critical supervisory and enforcement role within Spain.

Spain’s medical device framework is governed by Royal Decree 192/2023 (effective March 21, 2023), which consolidates national requirements with EU MDR and IVDR.

CE Marking Under EU MDR

To place a medical device on the Spanish market, CE marking under MDR is mandatory.

Key requirements include:

• Classification as Class I, IIa, IIb, or III
• Notified Body involvement for most devices beyond basic Class I
• Expanded clinical evaluation and clinical evidence requirements
• Implementation of a compliant Quality Management System (ISO 13485)
• Ongoing post market surveillance obligations

CE marking is granted following conformity assessment under MDR. AEMPS acts as Spain’s competent authority, while designated Notified Bodies perform conformity assessments.

Unlike legacy frameworks, CE certificates are subject to continuous oversight and MDR specific validity conditions. Documentation supporting compliance must be retained for at least five years.

Once CE marked, devices may circulate freely across EU and EEA markets, including Spain.

EUDAMED Registration 

Following the European Commission’s Implementing Decision (EU) 2025/2371 published November 27, 2025, the first four EUDAMED modules become mandatory on May 28, 2026. This represents a critical shift in EU medical device regulation.

Critical EUDAMED Deadlines:

• May 28, 2026: NEW devices must be registered in EUDAMED before placement on the EU market (including Spain)
• November 28, 2026: Legacy devices (already on market before May 28, 2026) must be registered
• May 28, 2027: Certificates issued before May 28, 2026 must be uploaded to EUDAMED

Registration Requirements:

Manufacturers placing devices on the Spanish market must:

• Register as an economic operator in the EUDAMED Actor module
• Obtain a Single Registration Number (SRN) before placing devices on the market
• Upload UDI and device data to the UDI/Device module
• Maintain accurate vigilance and post market reporting records in EUDAMED
• Ensure all device information is current and complete

Non-EU manufacturers must appoint an EU Authorized Representative, who assumes defined legal responsibilities under MDR and serves as the legal point of contact with competent authorities like AEMPS.

Important: EUDAMED registration is EU-wide and enables market access across all member states. However, Spain maintains additional national registration requirements (see below).

Spanish National Registration Requirements

While EUDAMED is mandatory EU-wide, Spain maintains additional national notification requirements through AEMPS. Both EUDAMED and Spanish national registration are required for market access.

Current System (2026):

Class IIa, IIb, and III devices:

• Must be notified to AEMPS through the CCPS application (Comunicación de Comercialización de Productos Sanitarios)
• Required before marketing in Spain
• Typically takes 90-180 days depending on device classification and documentation completeness

Class I and custom-made devices:

• Notification only required if the manufacturer, authorized representative, assembler, or sterilizer is established in Spain
• Notified through the Register of Responsible Entities
• Typically takes 30-60 days

Future System (Marketing Register – In Development):

Spain is transitioning to a new Marketing Register system that will eventually replace the CCPS process:

• All medical devices (except custom-made) will require notification through the Marketing Register
• Custom-made devices will continue to be notified through the Register of Responsible Entities
• Timeline for full implementation is still being finalized by AEMPS

Key Points:

• Spanish national registration is separate from and additional to EUDAMED registration
• Both are required for legal market access in Spain
• AEMPS may request additional documentation or clarification during the national registration process

Language and Labeling Requirements in Spain

Spain has comprehensive language requirements that extend beyond basic labeling:

Mandatory Spanish Language Requirements:

Labeling and Instructions for Use (IFU):

• Must be available in Spanish for all patient-facing and safety-critical materials
• Required for all devices marketed in Spain, regardless of classification
• Professional translation by certified translators familiar with medical device regulatory terminology is strongly recommended

Safety Information:

• Must be clearly translated using proper medical terminology
• Required warnings must be presented in full
• Risk information must be comprehensible to Spanish healthcare professionals and patients (where applicable)

Technical Documentation Submitted to AEMPS:

• Must be in Spanish for national registration applications (CCPS)
• Some clinical investigation documents may be accepted in English with Ethics Committee approval, but AEMPS retains the right to request Spanish translation
• All AEMPS correspondence and applications must be in Spanish

UDI and Labeling Compliance:

• UDI labeling must comply with MDR standards
• UDI-DI (Device Identifier) and UDI-PI (Production Identifier) must be present where required
• Spanish language must be used for all text elements on labels

AEMPS Communications:

• All official communications, inquiries, and submissions to AEMPS must be in Spanish
• Vigilance reports and post-market surveillance documentation must be in Spanish
• Field Safety Notices (FSN) must be issued in Spanish

Consequences of Non-Compliance:

Failure to meet language requirements can:

• Delay commercialization by 3-6 months
• Trigger corrective actions from AEMPS
• Result in market suspension until compliance is achieved
• Impact product liability and insurance coverage

Clinical Investigations in Spain (2026 Framework)

Clinical investigations conducted in Spain must comply with MDR clinical investigation requirements (Chapter VI, Annexes XIV and XV) and national procedures overseen by AEMPS.

Key Requirements:

Application Process:

• Submission of clinical investigation application to AEMPS
• Ethics Committee (CEIm) approval required
• Compliance with MDR documentation standards
• Both AEMPS and Ethics Committee must approve before study initiation

Documentation and Language:

• Most documentation must be in Spanish
• Limited exceptions: Investigator’s Manual and Clinical Investigation Plan may be accepted in English with Ethics Committee approval (at their discretion)
• Informed consent and patient information must always be in Spanish
• Protocol amendments must be submitted in Spanish

Safety Reporting:

• Serious Adverse Events (SAEs) must be reported according to MDR timelines
• Device deficiencies that could lead to serious adverse events must be reported immediately
• Annual safety reports required for ongoing studies

Spain remains an important location for clinical research, but sponsors must align with MDR clinical evidence expectations and national procedural requirements, including language obligations.

Vigilance and Post Market Surveillance

Post market surveillance is a central pillar of MDR enforcement in Spain.

Manufacturers must maintain:

• A documented Post Market Surveillance (PMS) plan
• Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices
• UDI based traceability systems
• Field Safety Corrective Action (FSCA) procedures
• Timely serious incident reporting to AEMPS and other appropriate authorities

Spain operates within the EU vigilance framework while AEMPS monitors compliance at the national level.

Supply Interruption Notifications

As of January 2025, Regulation (EU) 2024/1860 requires manufacturers to notify AEMPS and other competent authorities of any supply interruptions or discontinuations that could result in serious harm to patients.

Key requirements:

• Notification must be made as soon as the interruption is anticipated
• Must include information on alternative products or mitigation measures
• Applies to all devices marketed in Spain, regardless of classification
• Failure to notify can result in enforcement actions

Centralized Management

For manufacturers managing multi-market EU compliance, centralized tracking of vigilance activities is essential. Manufacturers must:

• Monitor incidents across all markets where devices are sold
• Report to multiple competent authorities according to each country’s requirements
• Maintain audit trails for all vigilance activities
• Coordinate Field Safety Notices in multiple languages

Key Takeaways for 2026

To successfully commercialize a medical device in Spain in 2026, manufacturers must:

• Ensure full compliance with EU MDR 2017/745 and Spanish Royal Decree 192/2023
• Obtain valid CE marking through the appropriate conformity assessment pathway
• Complete EUDAMED registration by mandatory deadlines:
  • NEW devices: Before May 28, 2026 placement on market
  • Legacy devices: By November 28, 2026
  • Certificates: By May 28, 2027

• Complete Spanish national registration:

• • Class IIa/IIb/III: CCPS notification to AEMPS (90-180 days)
  • Class I (if Spanish establishment): Register of Responsible Entities (30-60 days)
  • Prepare for transition to Marketing Register system
  • Appoint an EU Authorized Representative if located outside the EU

• Meet Spanish language requirements:

• • All labeling and IFU in Spanish
  • Technical documentation to AEMPS in Spanish
  • Clinical investigation materials in Spanish (with limited exceptions)
  • All AEMPS communications in Spanish

• Implement structured post-market surveillance and vigilance processes

• • Maintain PMS plans and PSURs
  • Report serious incidents to AEMPS
  • Issue Field Safety Notices in Spanish when required
  •  Notify AEMPS of supply interruptions per Regulation (EU) 2024/1860

• Implement ISO 13485 Quality Management System

• Plan for dual registration timelines

Spain’s dual registration requirements (EUDAMED + national) require careful planning and robust regulatory information management systems. As MDR enforcement continues to mature and EUDAMED becomes mandatory across Europe, manufacturers must adopt proactive regulatory strategies and centralized compliance systems to accelerate market access while reducing risk.