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.
But the MHRA has 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.”
However, these changes were in order to bring the UK into line with the EU.
Given the uncertainty over Brexit we need to watch what happens with legislation post whatever happens with Brexit.