References
EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products
Abstract
Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) (EU 2017/745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective.
The popularity of hyaluronic acid (HA) dermal filler procedures is growing. In 2018, the International Society of Plastic Surgery (ISAPS) reported an 11.6% rise in HA filler procedures, compared with the previous year (ISAPS, 2018). The public attitude seems to indicate that these procedures are becoming normalised (Cook and Dwyer, 2016; Davies, 2018). This raises the question of whether the public perceives dermal fillers as infallibly safe.
To ensure the safety and quality of medical devices, there are regulations that must be adhered to so that manufacturers can bring them to market. These regulations are implemented differently in various markets, as there is no global harmonisation (Vila Wagner and Schanze, 2019).
It was widely accepted that previous EU Medical Device Directive (MDD) standards were inadequate (Fouretier and Bertram, 2014). Manufacturers could shop around notified bodies in various countries for CE approval, in a commercial manner. Standards across the EU were not adequate, nor uniform between member states. There were high profile medical device failings, and changes to the regulatory framework were necessary and overdue (Cohen, 2012; Bowers, 2018).
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