Peter Roche (Galway East, Fine Gael)
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844. To ask the Minister for Health the way in which medical devices are regulated in Ireland; if medical devices are reimbursed by the State in a manner that is similar to pharmaceutical products; and if she will make a statement on the matter. [14117/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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In the EU, medical devices are regulated by way of an EU wide framework. A valid medical device bears a ‘CE’ mark, which indicates that it meets the basic requirements for safety and effectiveness under European law. 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

The Health Products Regulatory Authority is the agency in Ireland with responsibility of regulating medical devices for the benefit of people and the Department of Health engages closely with the HPRA on their remit.

The Health Service Executive (HSE) provides a wide range of aids and appliances free of charge to eligible people following assessment by a relevant health professional. These are provided through community services known as Community Funded Schemes and play a key role in assisting and supporting people to maintain everyday functioning, and to remain living in their homes and local community. A national list, including prescribing criteria, can be found at www.hse.ie/eng/services/list/2/primarycare/community-funded-schemes/aids-and-appliances/aids-and-appliances.html

Products classified as non-drug (medical devices) can be submitted for addition to the Reimbursement List for the certain categories found at this link: www.hse.ie/eng/about/who/cpu/non-drug-reimbursement-applications/. Additions to the Reimbursement List will be considered by the HSE in accordance with the Health (Supply and Pricing of Medical Goods) Act 2013.