As part of the whole-of-government response to Brexit, the Department of Health has established dedicated structures to manage the approach to preparing for the UK’s exit from the EU. The Department, the Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE), with the full support of stakeholders, are implementing a comprehensive and coordinated set of preparations to ensure continuity of health services and continued supply of medicine and medical devices in a ‘no deal’ Brexit.
The preparations include developing contingency plans to mitigate potential medical device supply problems arising from Brexit. Significant work has been undertaken by the Department of Health, the HPRA and HSE, together with industry, to minimise and address any risks to continuity of supply.
The HSE and the HPRA have facilitated ongoing engagements with manufacturers and suppliers of medical devices, to ensure that they are Brexit-ready, to discuss any potential issues that could affect the supply to Ireland and to identify solutions to maintain supply to the market.
The regulatory system for medical devices in the EU is reliant on pre-market conformity assessment of medical devices being conducted by certification organisations called notified bodies. Historically, a large number of medical devices available in the EU were assessed by notified bodies based in the UK. Post Brexit, all medical devices must be certified by notified bodies based in the EU 27.
There has been ongoing engagement with medical device suppliers and manufacturers to encourage swift action to move certifications from UK notified bodies to notified bodies based in the EU27 and many companies have taken corrective steps.
Manufacturers and suppliers of medical devices have been asked to further review their supply chain for products that travel from or through the UK, determine any products or services that are certified for compliance with EU standards by a UK body and communicate any potential vulnerabilities to the Department of Health, HPRA or HSE.
Work to monitor and manage risks to medical device supply is expected to continue in the months before and after Brexit. The Department of Health and the HPRA will also continue to engage with the European Commission to identify the most appropriate means to mitigate the risk to the supply of medical devices posed by a no-deal Brexit. However, it is important that industry takes immediate action to ensure their products will be compliant for placing on the EU market after 31 October.