MHRA confirms no plans to make fillers prescription only

30 Jan 2018

After days of speculation, the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that it has no plans in place to make dermal fillers prescription only.

The MHRA did confirm, however, that under European Regulations – EU 2017/745 – all dermal fillers will be regulated as medical devices from May 2020.

The new regulations are said to include clearer obligations for those involved in manufacturing and supplying devices, a greater emphasis on traceability throughout the whole supply chain with the introduction of a unique device identification (UDI) system and new standards for clinical evidence.

An MHRA spokesperson said, “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."

He concluded, “This is not the same as making dermal fillers prescription only and we have no plans to make such a change.”

Comments

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  • Mrs Barbata Pointon 31 Jan 2018 / 3:21 PM

    Oh dear. This announcement has really caused confusion, in particular as an MHRA Officer was present at the Aesthetics Nurses Conference where Sally updated from the regerence group that HA fillers would be PO by 2020.

  • Mrs Adele Dean 31 Jan 2018 / 7:13 PM

    Yes agree Barbara Pointon that the update at the conference has caused a considerable amount of confusion. It is concerning that such an announcement was incorrectly made by the MHRA in the first instance and very disappointed that there will be no safe regulation behind such ‘devices’

  • Mrs Adele Dean 31 Jan 2018 / 7:13 PM

    Yes agree Barbara Pointon that the update at the conference has caused a considerable amount of confusion. It is concerning that such an announcement was incorrectly made by the MHRA in the first instance and very disappointed that there will be no safe regulation behind such ‘devices’

  • Dr Bhavjit Kaur 04 Dec 2018 / 12:06 AM

    Brilliant baby steps to introduce some regulation in Medical Aesthetics