Medical Device Registration and Approval in United Kingdom

REGULATORY AUTHORITY: Medical devices in the UK are regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).

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

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:

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

From the day the UK leaves the EU, any medical device or an IVD placed on the UK market must be registered with the MHRA.

The MHRA will only register manufacturers that have a registered place of in the UK. If the manufacturer is based outside the UK, the manufacturer must assign a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device.

After exit day, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market.

Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine