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