Clarifying EU legislation EU 2017/745
There is some confusion surrounding Dermal Filler and the EU 2017/745 Medical Device legislation coming online in May 2020. It is not a (reclassification) of Dermal Filler to (POM) ‘Prescription only medicine’ rather, it is the broadening of the directive to include all dermal fillers as a Medical Device.
Before this legislation change dermal fillers that were marked as “Aesthetic Only Use” did not come under the current legislation standing as a Medical Device. Under the new legislation, all dermal fillers are classified as a medical device. This means all dermal fillers must have achieved a CE mark; in addition, a new (UDI) ‘ unique device identification’ must be implemented at the manufacturing level.
The new regulations are intended to provide more explicit obligations for those involved in manufacturing and supplying medical devices, a greater emphasis on traceability throughout the whole supply chain. Neither the MHRA (UK) or the HPRA (Ireland) have made any plans to reclassify Dermal Fillers as prescription-only medicine.