Supplying medical devices to Northern Ireland

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding medical device regulations in Northern Ireland following the implementation of the Northern Ireland Protocol. Since January 1, 2021, goods moving from Great Britain to Northern Ireland are classified as imports into the European Union. This shift means many Northern Ireland retailers and wholesalers have transitioned from being 'distributors' to 'importers,' a role that carries significantly higher legal and safety obligations. The regulatory framework is defined by the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. A primary concern addressed is the use of incorrect conformity markings; devices in Northern Ireland must carry a CE mark or a dual CE and UKNI mark to be legally sold. The UKCA mark, while valid in Great Britain, is insufficient for the Northern Ireland market. Required actions for businesses include verifying that manufacturers have applied the correct markings and ensuring that storage and transportation methods meet EU standards. Importers are also required to notify Great Britain-based manufacturers or Northern Ireland-based Authorised Representatives of their intent to import products. Furthermore, these entities must provide the MHRA with an updated list of active importers to maintain transparency within the medical supply chain. Businesses are advised to use the Trader Support Service to navigate these complex customs and regulatory changes.