General country-specific regulatory information is provided on this page for medical device registration and approval in Spain.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. in Spain, the responsible authority is Agency for Medicines and Health Products (AEMPS)
CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification.
Medical Devices: Class I (low), IIa, IIb, III (High)
IVD Devices: A (Low),B,C,D (high)
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I medical devices that would not require the involvement of a Notified Body and Class A IVD devices, For the other classes, it depends on the contract with the notified body and the type of device.I
SPECIAL REQUIREMENTS:
Audits: A Quality Management System ISO 13485 is required.
Technical Local Tests: There is no need for local tests.
Clinical Evaluation/studies: A Clinical Evaluation Report for all classes of medical devices and a Performance Evaluation report for IVD devices in accordance with the EU regulations and guidelines is required.
LOCAL FEES: Application review fees: As per the contract with the Notified Body or the costs of the relevant Competent authority within the EU for Class I MD/Class A IVD.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
LICENSE TRANSFER: Not applicable.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative located in the EU is required for manufacturers based outside the European Union to place their devices on the EU market.
ADDITIONAL INFORMATION: The CE mark is mandatory for market access in 30 countries, including 27 Member States of the European Union and three non-EU countries that are part of the European Free Trade Association (EFTA).EU Member States that require the CE mark for include the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, The CE mark is also mandatory for products subject to EU directives sold in the following EFTA countries: Iceland, Liechtenstein, Norway.
Registration in the EUDAMED system is required for entities operating in the EU, including manufacturers (both EU and non-EU), authorized representatives, and importers.
Class I CE-marked medical devices already marketed in the EU can be placed on the market without notifying the Regulatory Authority. For Class IIa, IIb, and III devices, manufacturers or EU Representatives must submit a notification via the CCPS portal
*Note: Specific requirements for local economic operators such as importers and distributors are not included here and may include both additional entity and device registration requirements.
For detailed device-specific compliance information for each market, including Spain, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
