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UKNI marking stands for the United Kingdom Northern Ireland marking, which is a new conformity marking to be used on various goods, including the medical devices that are being placed in Northern Ireland market. This is also represented as the UK(NI) mark or the UK(NI) indication. The legal basis for this marking is the United Kingdom Northern Ireland Protocol, which came into effect from 1st January 2021.

When and Where is the UKNI Marking of Medical Devices Valid?

The medical devices intended to be placed in Northern Ireland and whose conformity assessment is carried out by the Notified Bodies based in the UK shall have the UKNI marking on their labels. The UKNI marking is valid in Northern Ireland and will not be recognized in the European Union (EU) and the United Kingdom (UK).

What are the Timelines for the UKNI Marking of Medical Devices?

The Medical Device Regulations EU 2017/745 and IVDR regulations will be implemented along with the European Union (EU) i.e., 26th May 2021 and 26th May 2022, respectively.

What are the Rules for the UKNI marking of Medical Devices?

  • The manufacturer or the Authorized Representative is responsible for affixing the UKNI marking on the device labels and additionally to accompany with other conformity
  • The UKNI marking should always be accompanied by CE marking
  • Marking or sign which misconstrue or form the UKNI marking to the third parties are not allowed

Where to find the UKNI Images?

The original images with high resolution are found here. The images are available in various formats, such as GIF, JPG, PNG and EPS, for an easy use by the industry. The below mentioned are some of the criteria’s which are to be followed while affixing the UKNI mark on the device.

  • The mark is at least 5mm in height
  • The image is reduced or enlarged in such a way that the letters of the mark are in proportion to the original one
  • The mark should be visible, legible and permanently attached

The UKNI Mark and Device Labeling

From 1st January 2021, labels of medical devices intended to be placed in Northern Ireland and with the conformity assessment done through the Notified Bodies based in the UK shall include -  

  • CE marking
  • UKNI marking
  • Notified Body Number

Having said that, as the mandate is already in effect, it is time device manufacturers must comply with the UKNI marking obligations. Would you like to clearly understand how to add UKNI marking to your devices? Consult a proven device Regulatory expert.