Guidance for retailers: supplying medical devices to Northern Ireland

The Northern Ireland Protocol, part of the UK's withdrawal agreement from the EU, requires certain products on the Northern Irish market to comply with both EU and UK law. Medical devices in Northern Ireland must have a CE marking for EU compliance and may also require a UKNI mark. Northern Ireland retailers are now considered importers, requiring additional obligations, including conformity assessment and customs requirements. The specific requirements depend on the legislation used by the manufacturer.