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Devices are regulated by the EU list of Competent Authorities. Additionally, the Spanish Agency for Medicines and Medical Devices (AEMPS) must be informed before certain medical devices are placed on the market and/or put into service for the first time.
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.
The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device. The registration process with AEMPS can take up to six months.
Licenses issued in the EU are valid for five years. Registration with AEMPS does not require renewal.
An authorized representative anywhere in the European Union is required.
The Medical Device Directive is due to be changed in 2015.
Last updated on March 17 2015.
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For more information on registration in Spain and the EU, check out the following articles on our blog:
Country at a Glance: Spain
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2