Dáil Éireann Debate, Tuesday - 10 May 2022
805. Deputy Gino Kenny asked the Minister for Health if he will clarify the regulations in relation to non-surgical cosmetic treatments aesthetics; if his attention has been drawn to the proliferation of unregulated practices in the administration of these cosmetic procedures; the steps that he plans to take to regulate same; and if he will make a statement on the matter. [23294/22]
Amharc ar fhreagraThe manufacture and placing on the market of dermal fillers is regulated under Regulation (EU) 2017/745 (“MDR”.) The MDR, which became fully applicable in May 2021, has an expanded scope, and will specifically include all dermal fillers, including those without a medical purpose, within its scope once the technical requirements (known as common specifications) for these products are in place. Once the common specifications are adopted, all dermal fillers will need to be certified as medical devices under the MDR and undergo a premarket assessment by an independent conformity assessment body (a Notified Body) before they can be CE marked and placed on the market. The Health Products Regulatory Authority (HPRA) monitor the safety of medical devices in Ireland after they are placed on the market.
The MDR relates to the regulation of the medical device itself including matters such as safety and performance, as well as requirements for manufacturers of medical devices. It does not include provisions for the regulation of aspects relating to the use in practice or administration of the product, location of use, specific training or the qualifications of the individual administering the product. It is anticipated that the Department of Health will look at the wider aspects of the regulation of aesthetic procedures in 2022.
The HPRA monitor the safety of medical devices placed on the market and assess their compliance with the applicable legislation. A medical device that is in conformity with the applicable legislation should bear a CE mark, indicating that it meets the basic requirements for safety and effectiveness under EU law and in some cases, this will involve a separate assessment by a “Notified Body” before the device can be placed on the market. HPRA operate a medical devices compliance programme, the objective of which is to ensure that the provisions of the medical devices legislation are complied with, to help ensure that public health and patient safety are protected. Furthermore, the HPRA also operates a national incident reporting system for medical devices and users of medical devices are encouraged to report incidents or problems associated with their use, to the HPRA. Further information relating to this can be found on the HPRA website. See www.hpra.ie/homepage/medical-devices/safety-information/reporting-safety-issues
By way of additional information, with respect to cosmetic procedures, the Patient Safety (Licensing) Bill will introduce a licensing scheme for acute hospitals and higher risk clinical health services provided in other settings. These high-risk activities provided outside of the hospital setting are referred to in the Bill as “designated activities”. Designated activities will be provided for by regulation and are likely to initially include cosmetic surgery services. Research has been and will be carried out in this area to ensure that an appropriate list of high risk designated activities are identified for inclusion within this licensing scheme.
