After days of speculation, the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that it has no plans in place to make dermal fillers prescription only.
The MHRA did confirm, however, that under European Regulations – EU 2017/745 – all dermal fillers will be regulated as medical devices from May 2020.
The new regulations are said to include clearer obligations for those involved in manufacturing and supplying devices, a greater emphasis on traceability throughout the whole supply chain with the introduction of a unique device identification (UDI) system and new standards for clinical evidence.
An MHRA spokesperson said, “Dermal fillers currently placed on the UK market with a medical purpose are classed as medical devices and require a CE mark. There are, however, dermal fillers that are marketed for aesthetic use only that are not classified as medical devices as the manufacturer is not making a medical claim. The new legislation is addressing this regulatory anomaly by making all dermal fillers medical devices, irrespective of the claims attached to the product by the manufacturer."
He concluded, “This is not the same as making dermal fillers prescription only and we have no plans to make such a change.”