Marketing and Placing on the Market of Medical Devices and IVDs in Spain

EU Regulatory Requirements

Medical devices and IVDs placed on the Spanish market must fully comply with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Key obligations include:

• Affixing the CE marking after successful conformity assessment.
• Preparation of technical documentation and clinical evaluation/performance evaluation reports.
• Involvement of a notified body for Class IIa (in certain cases), IIb, III devices under MDR, and Classes B, C, D under IVDR.
• Declaration of conformity issued by the manufacturer.

Manufacturers outside the EU must appoint an authorised representative established in the Union. Comercialización y puesta en servicio en España de productos sanitarios y productos sanitarios de diagnóstico in vitro - AEMPS

National Registration Obligations in Spain

During transitional periods and for certain devices, additional national registration is required via the Spanish Registry of Medical Devices (Registro de Productos Sanitarios):

• Class I self-certified devices, custom-made devices, and systems/procedure packs must be registered with AEMPS before placing on the market.
• Transitional registration applies to legacy devices under MDR Article 120 and IVDR Article 110.
• Registration includes submission of device details, labelling in Spanish (where required), and responsible person information.

Failure to register can result in market restrictions or sanctions.

Labelling and Language Requirements

• Labelling must comply with Annex I of MDR/IVDR.
• Instructions for use and labelling must be provided in Spanish for devices intended for lay users or when required by national law.
• Minimum information includes UDI carrier, manufacturer details, intended purpose, and warnings.

Vigilance and Post-Market Obligations

• Serious incidents and field safety corrective actions must be reported to AEMPS without undue delay.
• Manufacturers maintain a vigilance system and conduct post-market surveillance, including periodic safety update reports where applicable.
• AEMPS coordinates with the EU vigilance network and may request corrective actions or market withdrawal.

Practical Steps for Market Access

1. Ensure CE marking and conformity assessment are complete.
2. Register in EUDAMED (mandatory for most devices).
3. Complete Spanish national registration if applicable (via AEMPS portal).
4. Appoint a local responsible person if required.
5. Prepare Spanish labelling and instructions.

AEMPS provides detailed guidance, registration forms, and updates on transitional provisions. Compliance ensures safe and legal market access across Spain and the EU single market. Comercialización y puesta en servicio en España de productos sanitarios y productos sanitarios de diagnóstico in vitro - AEMPS