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Medical devices in the UK are regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). Devices must have a CE Mark to be sold in the UK.
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.
The registration process takes about 6 weeks for Class I devices. For the other classes, it depends on the CE approval process.
Licenses are valid as long as the validity of the CE Mark. Licenses for Class I devices do not expire.
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