Plastic Surgery

(asked on 23rd April 2019) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will reclassify dermal fillers as prescription-only medicines.


Answered by
Jackie Doyle-Price Portrait
Jackie Doyle-Price
This question was answered on 29th April 2019

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 thus they are considered to be medical devices, although some manufacturers also indicate their products for aesthetic use as well.

Cosmetic dermal fillers placed on the market without any medical purpose being attributed to them by the manufacturer fall outside the scope of the Medical Devices Regulations, although in practice the majority of the products on the UK market are CE marked as medical devices.

From May 2020 all dermal fillers, irrespective of their composition and intended use, will be regulated as medical devices under Annex XVI of the Medical Device Regulations (EU 2017/745). The Regulations will significantly strengthen the quality assurance and safety of dermal fillers and ensure a consistent legal status of these products on the UK market. This will lead to a stronger market surveillance of these products.

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.

The Government is committed to the safe and effective regulation of medical devices in the UK; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.

Through the ‘no deal’ statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place, which will mirror all the key elements contained in Medical Device Regulations (EU 2017/745) and which will be brought into force in line with the transitional timetable being followed by the European Union for the full application of this Regulation.

Reticulating Splines