The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its plans to strengthen the regulation of medical devices as well as certain cosmetic products such as dermal fillers, to improve patient safety and to encourage innovation.
The plans come following the UK’s exit from the European Union. At the point that the UK left the EU, legislation was being introduced across Europe to set greater controls on the manufacture and supply of medical devices to ensure that they conformed with European safety standards. The MHRA undertook its own consultation on behalf of the UK Government, the results of which form the basis of the new plans.
The MHRA will be phasing out the existing ‘CE’ quality mark and introducing a new UK equivalent ‘UKCA’ quality mark. As well as dermal fillers, the package of reforms will apply to medical devices such as x-ray machines, new technologies such as smartphone apps and Artificial Intelligence (AI).
Amongst other things, the new measures will increase the scope and extent of regulation to better respond to public need, as well as enhancing systems that are already in place to better protect people using these products and devices, providing greater assurance of their performance and safety.
Victoria Brownlie, Chief Policy Officer at the British Beauty Council, commented “Part and parcel of our work to raise the reputation of our sector, particularly around aesthetics, these changes are another step forward in tightening up the quality, legitimate import and use of dermal fillers in the UK.”
The MHRA will phase in the new requirements, to give industry time to adapt to the change.
