What is the new UKNI marking for medical devices?

Find out more about the new UKNI marking for medical devices being placed on the Northern Ireland (NI) market.

Starting on 1 January 2021, medical devices that undergo mandatory third-party conformity assessments in the UK will be required to use the UKNI marking to be placed on the NI market, as per the Northern Ireland Protocol. The requirement reflects the fact that NI will continue to be subject to EU rules after Brexit.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the new UKNI marking, which explains when and how to use the marking.

The EU conformity marking ‘CE’ will still need to be used. If manufacturers use a UK notified body to carry out a conformity assessment, the UKNI marking will also need to be applied. The UKNI mark will always accompany a CE mark, and cannot be used on its own. However, the UKNI marking will not be recognised on the EU market. When placing medical devices on the EU market, the device must solely carry the CE marking, without the UKNI marking.

The guidance also outlines rules for placing the UKNI marking on a product or packaging, technical documentation requirements, and a useful table which clarifies accepted markings for different markets. It also includes a list of product areas covered by the UKNI marking.

For more information, click here.