UKCA Mark
UKCA Mark
for Medical Devices
UKCA Mark
for Medical Devices
Placing medical devices on the market in Great Britain after Brexit
The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland).
The UKCA mark is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE mark for sale in these markets.
UKCA Mark for Medical Devices
UKCA Mark for Medical Devices
Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023.
From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.
Where third party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark.
UKCA mark requirements are based on the requirements of the relevant Annexes to the Directives listed below, which are given effect in UK law through the UK MDR 2002 (as amended):
- directive 90/385/EEC on active implantable medical devices; (EU AIMDD)
- directive 93/42/EEC on medical devices; (EU MDD)
- directive 98/79/EC on in vitro diagnostic medical devices. (EU IVDD)
From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.
UKCA Approved Bodies
UKCA Approved Bodies
The MHRA can designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark.
Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically, without having to undergo a new designation process.
For the purposes of the Great Britain market, UK Approved Bodies can conduct conformity assessments in relation to the UKCA mark, for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (as amended).
UK Approved Bodies are not able to conduct conformity assessments in relation to the CE marking other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland.
The government has set up a new domestic UK database, UK Market Conformity Assessment Bodies, to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
See MHRA website
for more information.
Do you have products that need UKCA Mark?
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Do you have products that need UKCA Mark?
We are here to help you!
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