The Government has published guidance for businesses on moving goods to and from Northern Ireland under the Northern Ireland Protocol at the end of the transition period on 31 December 2020.
The announcement covers moving goods from:
- Northern Ireland to Great Britain
- Great Britain to Northern Ireland
- Northern Ireland to the European Union
- Northern Ireland to the rest of the world.
The guidance is designed to cover most goods, with specific guidance on medicines and other medical devices expected to follow shortly.
The guidance notes that medical devices will need to be compliant with the EU Medical Devices Regulation (MDR) from May 2021 and In Vitro Medical Devices Regulation (IVDR) from May 2022. Devices must be registered in Eudamed (for MDR-compliant products) and be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA). If the manufacturer is based in GB, the manufacturer will be required to have an Authorised Representative in Northern Ireland or the EU.
The full guidelines are available here. Once further guidance specific to medicines is announced MAP will provide an update.