Commercialization of Medical Devices in Spain – AEMPS Requirements

EU-Wide Requirements for Market Placement

Medical devices intended to be placed on the Spanish market must comply with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) as applicable. Essential steps include:

• Successful conformity assessment leading to CE marking.
• Technical documentation, clinical evaluation/performance evaluation, and declaration of conformity.
• For higher-risk classes (IIa in some cases, IIb, III under MDR; B, C, D under IVDR), involvement of a notified body is mandatory.
• Manufacturers outside the EU must appoint an authorised representative established in the Union.

These requirements ensure devices meet essential safety and performance criteria before commercialization. Comercialización de productos sanitarios en España - AEMPS

National Obligations in Spain

In addition to EU rules, Spain imposes specific national requirements managed by AEMPS:

• Registro de Productos Sanitarios (RPS): Mandatory registration before placing on the market for Class I self-certified devices, custom-made devices, systems/procedure packs, and legacy devices during transitional periods (MDR Art. 120, IVDR Art. 110).
• Labelling and Instructions: Must be provided in Spanish for devices intended for lay users or when national law requires it. Minimum information includes UDI, manufacturer details, intended purpose, and warnings.
• Economic Operators Registration: Manufacturers, importers, and distributors must be registered in the corresponding national operator registry.

Non-compliance with national registration can prevent legal commercialization and lead to sanctions.

Vigilance and Post-Market Surveillance

Once commercialized, devices are subject to continuous monitoring:

• Serious incidents, field safety corrective actions, and trends must be reported promptly to AEMPS.
• Manufacturers maintain post-market surveillance systems, including periodic safety update reports where required.
• AEMPS coordinates vigilance activities, may request corrective measures, and collaborates with the EU network for rapid risk communication.

Practical Steps for Manufacturers and Distributors

1. Complete CE marking and conformity assessment.
2. Register in EUDAMED (mandatory for most devices).
3. Fulfil Spanish RPS registration if applicable via the AEMPS portal.
4. Ensure Spanish-language labelling and instructions as needed.
5. Establish vigilance procedures and appoint a local responsible person if required.

AEMPS provides dedicated guidance, online registration tools, and updates on transitional arrangements to facilitate compliant commercialization. This dual EU-national framework balances harmonised safety standards with targeted national protections for the Spanish market. Comercialización de productos sanitarios en España - AEMPS