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MHRA announce consultation on the future regulation of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the UK, aiming to develop a new regime for medical devices.

Sajid Javid, Secretary of State for Health and Social Care, highlighted the central role of medical devices in changing the course of the pandemic, focussing on the opportunity to reshape such guidance following the UK’s departure from the EU.

The purpose of the updated regulation will be to enable earlier access to safe, effective and innovative medical products, supporting the Government’s ambition to be at the forefront of medical device adoption and adhering to the central belief that "Patient safety and innovation are not mutually exclusive, and we want to ensure that our regulations maximise both.”

As such, the new regulation will focus on creating new access pathways to support innovations, reforming in vitro diagnostics (IVD) regulation to update classification, becoming a sustainability pioneer through the safe re-use and re-manufacture of medical devices, and crucially for techUK’s members, creating a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices.

The consultation is open until 25 November 2021, and techUK will be working with members to submit a response.

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