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 £240 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 recognized in Great Britain until 30 June 2023 until, at the latest, 30 June 2030 depending on device type and classification. This applies to devices that have been CE marked under and fully conform with the applicable EU legislation.
- he EU no longer recognizes UK Notified Bodies, UK Notified Bodies are not able to issue CE certificates – and have become UK Approved Bodies
- The UKCA (UK Conformity Assessed) marking is a UK product marking used for medical & IVD devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.
- Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on 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
