Ciarán Cannon (Galway East, Fine Gael)
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24. To ask the Minister for Health the work that is being carried out by his Department to address the serious concerns that have arisen in respect of the implementation of the EU medical device directive. [53859/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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New EU regulations on medical and in vitro diagnostic devices have been fully applicable as of May 2021 and 2022, respectively.

Their overarching objectives are to significantly strengthen the regulatory system, provide a framework that is robust, consistent and enhances public health by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems, whilst supporting innovation.

I am aware that one of these regulations’ core implementation challenge relates to capacity in certifying devices under the new framework. I wish to acknowledge the work led by the Commission over recent months in responding to this and the helpful update provided by Commissioner for Health and Food Safety, Stella Kyriakides, in her recent address to the European Parliament. I would like to reiterate the Commissioner’s statement that patient access to safe medical devices is essential. I welcome in particular, the Commission’s move towards looking at a targeted legislative amendment to avert the risk of device shortages.

I look forward to intervening on this this matter, at tomorrow’s EPSCO meeting of EU Health Ministers in Brussels, where the Commission will provide an update on this matter.

The full and effective application of these regulations remains a priority for my Department and I. We will continue to work collaboratively with stakeholders to address the challenges faced with the overall objective of ensuring that the benefits of these regulations are realised in practice.