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Devices are regulated by the Medical Products Agency (MPA). Medical devices must have a CE Mark to be sold in Sweden.
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.
Licenses issued in the EU are valid for five years.
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 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