David Cullinane (Waterford, Sinn Fein)
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865. To ask the Minister for Health if the tethering devices used in vertebral body tethering procedures comply with EU Medical Device Regulations and relevant Irish safety standards. [16533/25]

David Cullinane (Waterford, Sinn Fein)
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867. To ask the Minister for Health how the procurement process for vertebral body tethering devices and associated implants has been managed; the suppliers that have been contracted to provide these devices; and whether procurement has followed HSE and EU Medical Device Regulations. [16535/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 865 and 867 together.

In 2017, two EU Regulations on medical and in vitro diagnostic devices (known as the ‘MDR’ and ‘IVDR’ respectively) came into force. The MDR became applicable in May 2021 (following a one-year delay as a result of the impact of COVID-19) and the IVDR became applicable in May 2022, also subject to some of its provisions being delayed. The objectives of the regulations are 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 whilst also supporting innovation.

Medical devices which are appropriately CE marked may be freely placed on the European market without further national authorisation.

The Department of Health is committed to the successful implementation of the EU Regulations

The questions on procurement are operational and for the Health Service Executive to answer. In this regard we have asked the HSE to reply directly to you.

In the event that there are concerns in relation to specific medical device, the HPRA can assist if details of the medical device(s) (e.g. product name and manufacturer name) in question are provided.