UK Conformity Assessment (UKCA)
The MHRA regulates medical devices, including in vitro diagnostic devices (IVDs), in Great Britain. In Northern Ireland, the EU MDR and IVDR apply.
What you need to sell in Great Britain
Register your device with the MHRA before you place it on the market.
Use the UKCA mark, or a CE mark that is still accepted. CE-marked devices are accepted for a transitional period. For devices certified under the EU MDR or IVDR, it ends on 30 June 2030. Devices certified under the older directives are accepted for a shorter time, or until the certificate expires if sooner. We will confirm the date that applies to your device. The government has said it will consult on accepting CE marking indefinitely.
If you are based outside the UK, appoint a UK Responsible Person (UKRP). The UKRP registers your devices with the MHRA, holds your technical documentation, deals with requests from the MHRA and reports safety issues. Their name and address go on the label.
How we help
We help manufacturers place devices on the UK, Northern Ireland and EU markets.
If you also sell in the EU or Northern Ireland, you need an EU Authorised Representative. EU-UK Authorised Representative Limited acts as your EU Authorised Representative (for the EU and Northern Ireland) and your UK Responsible Person, from one address in Belfast, Northern Ireland.
Our services include:
UKCA and UK MDR 2002 conformity assessment, and technical documentation.
UK Responsible Person services and MHRA registration.
EU Authorised Representative services for the EU and Northern Ireland, under the EU MDR and IVDR.
Importer services for the UK, Northern Ireland and the EU.
To discuss your device, please contact us.
Importers
If the importer into Great Britain is not the UK Responsible Person, it must tell the manufacturer or the UK Responsible Person before it imports a device. The UK Responsible Person then gives the MHRA a list of importers.
The importer’s name and address do not need to be on the label. The exception is when the importer also acts as the UK Responsible Person.
EU-UK Authorised Representative Limited acts as both your importer and your UK Responsible Person.
EU-UK Authorised Representative Limited
54 Bloomfield Avenue
Belfast BT5 5AD
Northern Ireland
Registered in Northern Ireland, company number NI674577