Currently, the Medicines and Healthcare Products Regulatory Agency only regulates dermal fillers that are placed on the United Kingdom market as medical devices, as defined in the Medical Devices Regulations 2002. The majority of these products are intended to be used in reconstructive surgery, and as a result they are considered to be medical devices.
The conformity of medical devices in general is approved by independent certification organisations called 'Notified Bodies'. As a result, medical devices are CE marked (rather than ‘approved’ or licenced), and a manufacturer is obliged to obtain a CE mark for their product via a Notified Body.
Dermal fillers come within the highest risk classification in the Medical Device Directive and as such, the manufacturer must be able to provide evidence of the safety, quality and performance of their product before they are granted a CE mark by the Notified Body and allowed on to the market.
Medical devices cannot be designated as “prescription only”, as this term only applies to medicinal products. The Government currently has no plans to introduce such a category for medical devices.