Louis O'Hara (Galway East, Sinn Fein)
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663. To ask the Minister for Health her plans to improve governance and safety regulations surrounding the use of aesthetic medical devices including dermal fillers as outlined in the Programme for Government; if she will implement a regulatory framework that limits the acquisition and administration of dermal fillers to qualified doctors and dentists; if there is a timeline for these plans; and if she will make a statement on the matter. [9149/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Dermal fillers are classified as medical devices under the European Union (EU) medical device legislation and the Health Products Regulatory Authority (HPRA) is the competent authority for medical devices in Ireland.

Dermal fillers are typically regulated under the Medical Devices Regulation (MDR) as Class III medical devices (the highest risk class). In the EU, medical devices are regulated by way of an EU-wide framework which aims to ensure that all devices available for use on the EU market are safe and perform as intended. A valid medical device bears a ‘CE’ mark, which indicates that it meets the basic requirements for safety and effectiveness under European law and can be placed on the EU market.

The Commission Implementing Regulation (EU) 2022/2346 requires all dermal fillers to be CE-marked subject to transitional timeframes. This regulation also requires the instructions for use to state that dermal fillers "are not to be used in persons who are less than 18 years old" and that they should only be administered by appropriately trained healthcare professionals.

The Department of Health is aware of the concerns in relation to the safe administration of dermal fillers and in this regard the Government has committed in its Programme for Government 2025 to ensure the administration of dermal fillers is only undertaken by trained healthcare professionals. The Department of Health is currently examining the most appropriate means to fulfil that commitment and at this stage in the process timelines can not be confirmed.

There are mandatory obligations for manufacturers to report incidents that occur with medical devices, including dermal fillers, to the HPRA. The HPRA asks individuals who have experienced any complications with the use of a dermal filler to report these to the HPRA through its online reporting system. The HPRA advises anyone who has health concerns relating to dermal fillers to contact their GP.