Matt Shanahan (Waterford, Independent)
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947. To ask the Minister for Health the reason that the Government has not called for the extension of Medical Device Directive certificates until the notified body capacity is resolved, to maintain patient access to vital medtech that are already safely in use in the market; and if he will make a statement on the matter. [54332/22]

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 vitro diagnostic 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 and 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 remains imperative that we continue to work collectively across the EU in identifying 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.