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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.
Last updated on January 6th, 2022.
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).
CLASSIFICATION SYSTEM:
Medical devices: Classified according to risk into Classes I, IIa, IIb, and III.
IVD Devices: Same as the EU IVDD– List A & B, Self testing, all others
TIMEFRAME: The registration process takes about 6 weeks.
LOCAL FEES: Where any new registrations or changes to existing registrations are made, a Є100 standard fee will be applied per application.
LICENSE VALIDITY: Licenses are valid as long as the validity of the CE Mark. Licenses for Class I devices do not expire.
AUTHORIZED REPRESENTATIVE: to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.
ADDITIONAL INFORMATION:
- all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
For detailed device-specific compliance information for each market, including United Kingdom, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
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