Ireland is a well-established location for the production and distribution of medicines and medical devices with mature long established industries across the main subsectors. After Brexit establishment in Ireland will guarantee continued access to the European Union market without customs duties, customs processes or regulatory checks

Ireland will continue to have access to both the Irish and the UK labour markets. Professional qualifications in the relevant areas will continue to have automatic / or facilitated recognition under the EU framework for recognition of qualifications. Employees and service providers may come to Ireland to work or provide services and bring their family if they choose to do so.

Ireland is subject to the EU wide regulation on the safety and performance of medical devices. Devices are classified in accordance with their intended purpose and their inherent risks. There are common rules on clinical investigations and data and on manufacturers obligations. There is a uniform system of rules designed to ensure traceability incident reporting and market surveillance.

Manufacturers are subject to a common EU rulebook. The extent of the obligations depends on the nature of the device concerned and its risk profile. Class I generally is regarded as low risk, class II medium risk and class III high risk. Manufacturers of low risk device can self-declare conformity before affixing CE marking. High risk device must be certified by an independent conformity assessment body designated as an EU notified body before the CE marking can be affixed

The UK notified bodies are no longer competent to undertake this function after Brexit. EU labelling requirements continue to apply after Brexit which must include notified body number.A medical device must be registered with an EU regulator or recognised body in appropriate EU states such as Ireland.

In the absence of medicines having an EU origin, importers are subject to additional obligations to ensure that the device has been manufactured and CE marked in accordance with EU standards, that the manufacturer has an EU responsible person where required, that the device is duly registered with the relevant agency and that it has been labelled correctly with the appropriate identifier. Intra-EU distributors have similar but less onerous obligations.