United Kingdom
REGULATORY AUTHORITY: 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.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 6 weeks for Class I devices. For the other classes, it depends on the CE approval process.

LICENSE VALIDITY: Licenses are valid as long as the validity of the CE Mark. Licenses for Class I devices do 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.



ARE YOU INTERESTED IN REGISTRATION IN THE EU? REQUEST A FREE QUOTE>​

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
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