What are the requirements in Northern Ireland?
The United Kingdom is made up of four countries: England, Scotland, Wales and Northern Ireland. All four countries left the European Union in the so-called ‘Brexit’. Collectively England, Scotland and Wales make up Great Britain. While Northern Ireland is a UK country, they are not part of Great Britain.
Northern Ireland requires, and will continue to require, European CE marking. The MDR and IVDR dates of application are mandatory in Northern Ireland, just as they are throughout the European Union.
This includes all of the requirements needed to meet CE marking, such as: compilation of the technical documentation file compliant to the EU Directives/Regulations, as applicable; appointment of a European Authorized Representative; registration of Economic Operators and devices; appointment of Person Responsible for Regulatory Compliance; market surveillance; post-market surveillance; vigilance monitoring and reporting.
Unlike the rest of the UK, Northern Ireland will not implement or recognize UKCA marking. Many of the above CE marking requirements differ from UKCA requirements.
Currently manufacturers may place CE marked devices onto the Great Britain market, as long as they have met the requirement to appoint a UK Responsible Person and register their devices with the MHRA. That allowance was originally supposed to end on 30 June 2023; however, the MHRA postponed it by one year, to July 2024. Additionally, the MHRA will provide a further 3-5 transition period.
After the transition period ends, devices must be UKCA marked in order to be placed onto the Great Britain market. Once this occurs, the requirements between the Great Britain and Northern Ireland will more fully diverge.
For more information the UKCA marking transition dates, please read: MHRA Officially Postpones UKCA Marking