Medical devices bearing the UKCA Mark indicate that they meet the requirements of the UK. Test results show that the device meets applicable legislation requirements. If the UKCA stamp is present on the product, the product can be freely marketed in Great Britain (England, Wales, and Scotland).
However, UKCA Certification won’t be recognized in Northern Ireland or the EU. For devices placed on the Northern Ireland market, a CE mark or a CE UKNI mark will be required.
UKCA marks must be accompanied by a ‘declaration of conformity, i.e., the UKCA Conformity.
If the UK Approved Body has been involved in conformity assessment for certain higher-risk devices (Class Is, Im, IIa, IIb, III, self-test IVDs), there is a specific identification number as below.
- UK government has set up a new domestic database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
- The UKCA mark can be used by manufacturers until 30 June 2023. A UKCA Mark will be required for the sale of medical devices in Great Britain as of 1 July 2023.
- Use of the UKCA mark is exempt from these rules.
- Medical devices should not be marked with the UKCA if they are:
- Customized medical devices: It is still necessary to comply with the UK MDR 2002 requirements when using a custom-made device, and to clearly indicate its type;
- Involved in a clinical trial: There must be a statement that the study is exclusive to clinical research;
- In-vitro diagnostic medical devices (IVDs) are used to assess the performance of medical devices;
- Devices that are not compliant but are used in exceptional circumstances (humanitarian reasons).
There is no need for third-party intervention in the above cases. However, there is a possibility that you may have to draw up a statement to declare compliance for custom-made devices, clinical investigations, and performance evaluation devices in some cases.
Medical Devices Must Be Marked by UKCA
The Medicines and Healthcare Products Regulatory Agency requires all medical devices placed on the market to be registered with them. It will oversee all devices on the UK market and implement vigilance, sampling, reporting, and incident management. This allows UKCA Marking in UAE manufacturers to register their products directly. For the registration of their products, manufacturers outside of the United Kingdom will need to appoint a Responsible Person.
We, at Ascent, are committed to helping our customers implement UKCA Marking. As soon as we’re designated as a UK Approved Body and develop a robust conformity assessment process for the UKCA.
Due to the extensive experience of our two European Notified Bodies and our existing network and infrastructure in the United Kingdom, the process is facilitated in a smooth manner.