Dermal Fillers, May 2020 and the MHRA
There is still a little confusion over plans for dermal fillers and whether they will be classed as a prescription only medicine.
They WILL NOT in the near future.
The MHRA (Medicines and Healthcare Products Regulatory Agency) has confirmed that it has no plans to make dermal fillers prescription only.
This statement follows a certain amount of speculation in the industry and concern among those non-prescribing practitioners who are currently able to use dermal fillers without the need for a prescription from a suitably qualified prescriber.
However, there are changes afoot to better control the products available in the UK, as the MHRA plan to regulate dermal fillers as medical devices.
The MHRA confirmed that all dermal fillers will be regulated as medical devices from May 2020 under European Regulations EU 2017/745. A spokesperson for the MHRA explained:
“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.
“This is not the same as making dermal fillers prescription only and we have no plans to make such a change.”
The news that dermal filler products will be regulated as medical devices has been warmly received by professionals within the industry, who say that the lack of control around products exposes clients to significant risk, as practitioners are able to import unknown fillers, offer them at extremely low prices and inject without any restriction. The classification of dermal fillers as medical device will effectively end this practice.