Medical Device Registration and Approval in United Kingdom

General country-specific regulatory information is provided on this page for medical device registration and approval in United Kingdom. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including United Kingdom, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in 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.

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