Éamon Ó Cuív (Galway West, Fianna Fail)
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134. To ask the Minister for Health if he has raised concerns at EU level in relation to the short-term effect of the medical device regulation, which came into effect on 26 May 2021; if subject to a risk-based roll-out he will be looking for the deferment of the implementation of the directive from 2024 to 2027 and allow the use of existing stock after 2025; and if he will make a statement on the matter. [55796/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Regulation (EU) 2017/745 on medical devices (‘MDR’) has been fully applicable as of 26 May 2021 and Regulation (EU) 2017/746 on in vitrodiagnostic medical devices (‘IVDR’) became fully applicable as of 26 May 2022.

The overarching objectives of these new regulations is to significantly strengthen the regulatory system for medical devices and provide a framework that is robust and consistent and serves to enhance public health across the EU by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems.

Implementation of the new regulations has not been without challenge, and I am aware that one of the key challenges in implementing these regulations relates to the capacity of the system in certifying devices under the new framework, which has been compounded by the Covid-19 pandemic. There are indeed other challenges associated with implementation of the new regulatory framework.

My officials are kept in full brief on these issues through engagements with the Health Products Regulatory Authority (HPRA) and EU fora and my department is working via these fora in considering and addressing these challenges and working towards the effective implementation of the regulations, ensuring that healthcare systems and patients have access to safe medical devices. My Department is fully committed to continuing to work with key stakeholders in this regard, in identifying and reaching pragmatic and necessary solutions to these challenges.

It is important to recall Minister Feighan’s intervention at the EPSCO Health Council meeting in June earlier this year, in which he spoke to Ireland’s concerns regarding implementation of these new regulations. Ireland’s lead Member State intervention was well-supported. The European Commission committed to keeping EPSCO informed of progress on the response to the matters raised, including to report back on same at the next EPSCO in December. It must be noted that considerable work has been ongoing since June at EU level in response to the certificate capacity issue including the much welcomed publication of an action plan by the Medical Devices Coordination Group (MDCG), implementation of which is imperative and a responsibility incumbent on all stakeholders.

Ireland continues to work actively and collaboratively with our EU partners on monitoring this situation and considering whether any further actions are required. I can assure you that this remains a priority for my Department and our commitment in this regard is unwavering. It remains imperative that we continue to work collectively across the EU in harmonized solutions to these challenges in order to ensure that the new regulatory system is effective in practice and delivers on its objectives.

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