Spanish Medical Device Market Entry: AEMPS Registration and Language Mandates

Spanish Medical Device Market Entry: The AEMPS and National Steps

The Spanish medical device market is regulated by the European Medical Device Regulation (EU MDR), with national oversight provided by the Spanish Agency for Medicines and Medical Devices (AEMPS) (Agencia Española de Medicamentos y Productos Sanitarios). Manufacturers must combine CE Marking acquisition with specific Spanish national procedures.

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1. The Spanish National Registration Process

Once a device has obtained the CE Mark, the manufacturer or their EU Authorized Representative (AR) must complete the mandatory national registration with the AEMPS.

• AEMPS Notification: Registration must be completed through the AEMPS online portal via an Initial Submission. This applies to most devices, though requirements vary significantly by classification.
• Timeline: The regulatory review period for the initial submission typically ranges from 30 to 90 days, depending on the complexity of the device (Class I vs. Class III) and the completeness of the documentation.
• In-Country Representative: While the EU AR manages EU-level compliance, non-Spanish manufacturers often designate an In-Country Representative to serve as a local regulatory contact point within Spain.

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2. Language and Documentation Compliance

Spain, like many other large EU member states, enforces strict language mandates for patient safety.

• Mandatory Spanish Language: All safety-critical and patient-facing materials, including the Instructions for Use (IFUs), labeling, and clinical documentation provided to healthcare professionals, must be provided in the Spanish language. This goes beyond the basic MDR multilingual provisions.
• Documentation Standards: AEMPS places particular emphasis on the adequacy of clinical data and the completeness of the Technical File during the review process.

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3. Classification-Based Requirements

The regulatory burden in Spain scales based on the device's risk classification:

• Class I Devices: These typically require simpler AEMPS notification after self-certification. However, sterile Class I and measuring Class I devices require limited involvement from a Notified Body, making their registration slightly more complex than basic Class I devices.
• Higher-Risk Devices (IIa, IIb, III): These classes require extensive Notified Body involvement, rigorous Post-Market Surveillance (PMS) systems, and detailed clinical evidence, leading to longer AEMPS review periods and ongoing regulatory obligations like annual renewals and enhanced adverse event reporting.