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MHRA consultation and potential extension of medical device regulation

Posted on 1 November 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently launched a 10-week consultation, which provides medical practitioners to the general public an opportunity to contribute and have their say in shaping the future of the regulatory framework for medical devices in the UK. The aim of the consultation is to provide a future regime which is focused on improving patient safety, providing greater transparency and product information, closer alignment with international best practice, and more flexible and responsive regulation of medical devices which form an integral part of our everyday lives.

Medical devices and in vitro diagnostic medical devices (IVDs) are currently regulated under the Medical Devices Regulations 2002 (the UK Medical Devices Regulations), which transposed three European Union medical devices Directives into UK law. Only products falling within the definition of either a medical device or an IVD are regulated under the UK Medical Devices Regulations. The MHRA is now considering broadening the scope of the devices regulated to include certain products which do not have any intended medical purpose but which share certain similarities with medical devices in terms of their functioning and risk profile.A

There are several products on the market which manufacturers claim have a purely aesthetic or non-medical purpose but which have the potential to cause risks similar to medical devices such as infection or injury. The MHRA has suggested that these would include coloured lenses, buttock implants, dermal fillers and hair removal lasers. While these products are not currently regulated under the UK Medical Devices Regulations, they may still have to comply with other regulations such as the General Product Safety Regulations 2005.

The MHRA has recognised this as an opportunity to potentially regulate such products and thereby ensure that they meet higher standards of safety before, once and after they are marketed to consumers. Under the UK Medical Devices Regulations, medical devices cannot be marketed in the UK without carrying a UKCA or CE marking (the CE marking will no longer be valid for goods placed on the GB market after 1 January 2023).  Manufacturers are also required to support their performance claims for the medical device which is more onerous in the case of higher risk medical devices. Once the medical device is marketed, the manufacturer must continue assessing the safety and performance of the device and also has reporting obligations to report certain incidents to the MHRA.

While the MHRA has recognised that its proposed approach could impose additional burdens on manufacturers and detract from the favourability of the UK as a market for medical devices, it maintains that the changes will improve the overall protection of consumers and bring the UK into alignment with international best practice and regulatory requirements with other international regulators' jurisdictions.

For instance, all dermal fillers marketed in the EU are already regulated as medical devices under European Regulation EU 2017/745. Under the current legislation in the UK, while dermal fillers placed on the market with a medical purpose are classified as medical devices, dermal fillers marketed for aesthetic purposes only are not currently classed and regulated as medical devices. Bringing all dermal fillers within the scope of the UK Medical Devices Regulations will address this lacuna in the law and improve quality assurance and safety of dermal fillers marketed to UK consumers.

Similarly the U.S. Food and Drug Administration (FDA) has clarified that decorative and non-prescription contact lenses are not cosmetics or over-the-counter merchandise but are in fact medical devices regulated by the FDA. An eye doctor must measure each eye to properly fit the lenses and assess how the eye responds to contact lens wear, as a poor fit can cause serious eye damage ranging from scratches on the cornea and corneal infection to blindness.

Responses to the consultation will vary depending on whether the person responding is a manufacturer, healthcare professional or a member of the public as each stakeholder group will have varying priorities. It will be interesting to see the result of the consultation, which closes on 25 November 2021, as it will have a major impact on the future of the regulation of aesthetic and beauty products in the UK.

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