The MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety

A consultation has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will close on 5 January 2025.

The consultation will focus on four policy areas that have evolved significantly since the MHRA’s initial consultation to strengthen medical devices legislation was launched in 2021. These four areas, described below, are part of broader regulatory reforms that respond to recommendations set out in the Independent Medicines and Medical Devices Safety (IMMDS) review and that support the development of a regulatory framework that enables transformative technologies to reach patients as quickly and safely as possible.

The findings from this latest consultation will inform new legislation, the Pre-market Statutory Instrument, which we expect to be laid in Parliament next year. This follows the laying of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations in Parliament on 21 October 2024.

Together, these reforms will boost UK patients’ access to safe and innovative medical products, and will help the government’s efforts to eradicate health inequalities, get the NHS back on its feet and kickstart growth across the country.

The four policy areas that the MHRA is consulting on are:

1. UKCA marking
2. International reliance
3. In vitro diagnostic (IVDs) devices
4. Assimilated EU law.

This proposal – alongside more specific transitional provisions – would ensure a smooth transition to a future regulatory framework, which aims to protect patient safety, improve access to innovative medical devices, and support innovation.

You can take part in the consultation here. The MHRA welcomes views from all interested stakeholders.

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Source: MHRA, 14 November 2024