Health | To ask the Minister for Health the extent to which his attention has been drawn to the difficulties affecting the availability of medical devices throughout the country
To ask the Minister for Health the extent to which his attention has been drawn to the difficulties affecting the availability of medical devices throughout the country; if measures are in hand to resolve any issues; and if he will make a statement on the matter.
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) becomes fully applicable as of 26 May 2022. The aim of these new regulations is to provide a robust and consistent regulatory framework for medical devices and enhance public health across the EU, by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems.
One of the challenges in implementing these new regulations, relates to the capacity of notified bodies certifying devices under the new regulatory framework, which has indeed been compounded by the Covid-19 pandemic. My department is working closely with the Health Products Regulatory Authority (HPRA) and the EU in considering and addressing this important matter as a priority. It is important to reiterate that full and effective implementation of the new regulatory framework remains a key priority for my department.
To address the specific query regarding difficulties affecting the availability of medical devices, I can confirm that the HPRA has not been informed of specific device shortages in Ireland. The HPRA does encourage medical devices stakeholders, including economic operators, healthcare institutions and healthcare professionals to raise any specific medical device shortages that may relate to Notified Body capacity issues directly with them.
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