MEDICAL DEVICE REGISTRATION AND APPROVAL IN United Kingdom

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 update: December 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: BelarusBosnia & HerzegovinaIcelandLiechtensteinMacedoniaMoldovaNorwaySerbiaSwitzerlandTurkey, Ukraine

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?