Tuesday, 12 October 2021
Department of Health
The manufacture and placing on the market of dermal fillers is regulated under the Medical Devices 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 the scope of the legislation once the technical requirements (known as Common Specifications) for these products are in place. Once the Common Specifications are adopted, all dermal fillers must be certified as medical devices and undergo a pre-market assessment by an independent conformity assessment body (a Notified Body) before they can be CE marked and placed on the market. The HPRA monitor the safety of medical devices in Ireland after they are placed on the market. The HPRA also operates a national reporting system for medical devices where users of devices are encouraged to report incidents or problems associated with their use, to the HPRA.
The MDR relates to the regulation of the product itself and the requirements for manufacturers of the products. It does not include provision for 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. Certain users of these devices will be regulated professionals. Further consideration by the Department of Health may be required in this regard in the future.