A UKCA mark is a logo that is affixed on medical devices to show they conform to the requirements in the UK MDR 2002;
It shows that the device is fit for its intended purpose stated and meets applicable legislation requirements;
It shows the product can be freely marketed in Great Britain (England, Wales and Scotland) The UKCA mark will not be recognised on the Northern Ireland nor EU market. A CE mark or CE UKNI mark will be needed for devices placed on the Northern Ireland market.
You must sign a ‘declaration of conformity’ before you can place the UKCA mark on your product.
An identification number for an UK Approved Body needs to be placed below the UKCA mark if it has been involved in the conformity assessment for certain higher-risk devices Class Is, Im, IIa, IIb, III, self-test IVDs, Annex II IVDs).
The UK government has set up a new domestic UK database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System where you can find the UK Approved Bodies.
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 medical device on the Great Britain market.
Exemptions to the use of the UKCA mark:
You should not place a UKCA mark on your medical device if it is:
- A custom-made device – although it must still meet the requirements in the UK MDR 2002 and the type of device should be labelled clearly;
- Undergoing a clinical investigation – it must include ‘exclusively for clinical investigation’;
- An in-vitro diagnostic medical device (IVD) for performance evaluation;
- A non-compliant device used in exceptional circumstances (humanitarian grounds)
No third-party intervention is needed in above cases, but you need to for ex. draw up a statement to declare the compliance for custom-made devices, clinical investigations and performance evaluation devices.