Devices are regulated by the EU list of Competent Authorities. The Latvian State Agency of Medicines (SAM) requires additional notification for Class IIb, III, AIMD and some IVD devices. Registration with the SAM is also required for manufacturers located in Latvia. CLASSIFICATION SYSTEM:
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
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. LICENSE VALIDITY:
Licenses issued in the EU are valid for five years. The registration certificate issued by the SAM does not expire. AUTHORIZED REPRESENTATIVE:
An authorized representative anywhere in the European Union is required. ADDITIONAL INFORMATION:
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 the EU, check out the following articles on our blog: 5 Questions and Answers: Additional Regulations in the EU 4 Steps to Comply With EU Directive RoHS 2