National requirements for the approval of medical devices in Spain
Spain is one of the largest markets for medical technology in Europe and, as an EU member state, is subject to the Medical Device Regulation (MDR 2017/745) as well as supplementary national regulations. In addition to CE marking, there are specific requirements for the registration, market surveillance and reimbursement of medical devices.
This article provides an overview of the national requirements in Spain that go beyond the general EU requirements.
Competent authority for medical devices in Spain
The regulation and market surveillance of medical devices is carried out by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), which reports to the Spanish Ministry of Health.
Tasks of the AEMPS
- Approval and monitoring of medical devices
- Evaluation of clinical trials
- Approval and registration of manufacturers and products
- Monitoring of vigilance messages and security reports
Further information on the AEMPS is available on the official website:
www.aemps.gob.es
Mandatory registration for medical devices in Spain
In addition to EU-wide registration in EUDAMED, certain medical devices in Spain must be registered with the AEMPS before being placed on the market.
Registration obligation for manufacturers and products
- Manufacturers based in Spain must register with the AEMPS.
- Class I medical devices must be notified before being placed on the market.
- Manufacturers of in-vitro diagnostics (IVD) must register in a separate AEMPS database.
- Medical devices with special properties, such as sterilized or custom-made products, are subject to separate reporting requirements.
Registration process in Spain
- Creation of a user account in the AEMPS registration system
- Registration of the manufacturer or authorized representative (EU-AR)
- Input of product data, including CE certificate and technical information
- Submission of the registration via the AEMPS portal
- Confirmation by the AEMPS
The processing time is usually a few weeks to a few months.
Need for a local representative in Spain
Manufacturers based outside the European Union must appoint an Authorized Representative (EU-AR) to register and market their products in Spain.
Obligations of the authorized representative (EU-AR)
- Communication with the Spanish authorities (AEMPS)
- Registration in the AEMPS database for manufacturers outside the EU
- Checking the technical documentation for conformity
Manufacturers based in Spain do not need an additional authorized representative, but must meet all regulatory requirements.
Classification of medical devices in Spain
Medical devices are classified in accordance with the EU Medical Device Regulation (MDR 2017/745) and do not differ from other EU member states.
Classification according to MDR
- Class I - Low risk (e.g. dressings, surgical instruments)
- Class IIa - Medium risk (e.g. infusion pumps, ultrasound devices)
- Class IIb - Higher risk (e.g. anesthesia machines, defibrillators)
- Class III - High risk (e.g. heart valves, artificial joints)
Special classifications in Spain
Some product groups are subject to additional national requirements, in particular:
- Custom-made medical devices - registration and additional documentation requirements
- Sterilized products - mandatory reporting to the AEMPS
- Products with animal ingredients - Special verification requirements
Approval procedure for medical devices in Spain
A medical device is approved throughout the EU via the CE marking. However, Spain has additional requirements for market launch and reimbursement by the public healthcare system.
What approval procedures are there?
- CE marking according to MDR - mandatory for market entry
- Registration in the AEMPS database for certain products
- Additional requirements for high-risk products - approval by the AEMPS required
Reimbursement procedure for medical devices in Spain
In addition to regulatory approval, reimbursement by the Spanish healthcare system (SNS - Sistema Nacional de Salud) is a decisive factor for market success.
Important reimbursement procedures:
- Inclusion en la Cartera de Servicios Comunes del SNS
- Inclusion in the list of reimbursable medical devices
- Approval required from the Ministry of Health
- Evaluation by the Agencia de Evaluación de Tecnologías Sanitarias (AETS)
- Evaluation of the clinical efficacy of a medical device for inclusion in reimbursement
Average duration of approval procedures
- CE marking: 3 to 24 months depending on product class
- AEMPS registration: A few weeks to a few months
- Reimbursement procedure: 6 to 24 months, depending on the procedure
Costs incurred
- AEMPS registration: No direct fees for most products
- Notified body for CE certification: Depending on product class (10,000 - 100,000 euros)
- Reimbursement procedure: Costs for studies and applications can be high
Validity of registration and approval
- CE marking is generally valid for 5 years
- AEMPS registration remains valid as long as the product is actively marketed
Language requirements
- Technical documentation can be submitted in English
- Instructions for use, labels and packaging must be available in Spanish
Conclusion
Spain is an important medical technology market with additional national requirements for the registration and reimbursement of medical devices.
Important points summarized:
- AEMPS registration is mandatory for certain medical devices
- Non-EU manufacturers require an authorized representative (EU-AR)
- Special requirements for custom-made, sterilized and high-risk products
- Reimbursement processes are crucial for market success
- Technical documentation can be submitted in English, labels and instructions for use must be in Spanish
Support from MEDAGENT
MEDAGENT offers comprehensive services for the Spanish market:
- Registration with the AEMPS
- Advice on CE marking and technical documentation
- Support for post-market surveillance and vigilance
- Guidance through the reimbursement process with health insurance companies
For more information or assistance with the approval of medical devices in Spain, please contact us directly.
