Northern Ireland is a part of the customs territory of the United Kingdom. However, after the Brexit technical regulations, assessments, registrations, certification procedure as well as approvals are carried out in the NI within the Northern Ireland Protocol. Thus, rules for putting medical devices to the NI market differ from the rules that are applicable in the UK.

So, if the manufacturers want to place their medical devices on the NI market, they should remember that:

• Legislation of the EU is applicable in the NI and requirements of the EU MDR must be met in the NI starting from May 26, 2021.
• Some medical devices should be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) within the following timeline:     - for Class IIIs and Class IIb implantables, and all active implantable medical devices must be registered from May 1, 2021    - other Class IIb and all Class IIa devices must be registered from September 1, 2021
• The device must be CE marked
  

In case when the manufacturer is located in the UK, he should observe the following provisions to put the device to the NI market:

• Has EU- or Northern-Ireland-based Authorized Representative
• When using a UK notified body within the certification procedure, the UKNI mark must be indicated on the device.
  

Please, note that the UKNI marking is never applied by its own but is accompanied by the CE marking when importing to the NI market. However, CE + UKNI marking on the device cannot be acceptable for the EU market.

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The information has been prepared by the GMA Consult Group team. ‍

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

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