Devices are regulated by the Medical Products Agency (MPA). Medical devices must have a CE Mark to be sold in Sweden. 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. 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