Commercializing Medical Devices: AEMPS Notification

Essential Steps for Medical Device Commercialization in Spain

To legally market and sell medical devices in Spain, manufacturers must navigate the regulatory landscape set by the European Medical Device Regulation (EU MDR) and enforced nationally by the Spanish Agency for Medicines and Medical Devices (AEMPS). These practical steps are non-negotiable for compliance.

1. Mandatory National Notification to AEMPS

While the CE Mark allows free movement of goods, Spain requires a national notification for market surveillance purposes.

• AEMPS Registration: All devices placed on the Spanish market must be notified to the AEMPS database. This applies to devices of all risk classifications (Class I, IIa, IIb, III).
• Notification Responsibility: For non-EU manufacturers, the EU Authorized Representative (AR) is legally responsible for submitting this notification to the AEMPS on the manufacturer's behalf. This process ensures the AR is properly registered in Spain to act as the legal point of contact.

2. Strict Language Compliance (Spanish Mandate)

One of the most critical practical requirements for commercialization in Spain is language compliance.

• Spanish Language Requirement: All documents necessary for the safe and proper use of the device, including Instructions for Use (IFUs), labeling, and technical promotional materials targeting end-users and patients, must be provided in the Spanish language. This is an absolute national prerequisite for legality.
• Accuracy: Translations must be accurate and use the correct technical terminology to avoid non-compliance actions by AEMPS.

3. Vigilance and Post-Market Duties

AEMPS maintains strict oversight post-market, demanding prompt action from manufacturers and their AR.

• Vigilance Reporting: The AR must promptly report any serious adverse incidents or Field Safety Corrective Actions (FSCAs) occurring in Spain to the AEMPS.
• Market Surveillance: AEMPS actively monitors the market and may request additional documentation or clarification on registered devices. Manufacturers must ensure their technical files and QMS records are readily available to the AR for communication with the Spanish authority.