Launch of MHRA Public Consultation Over Medical Device Regulation
By launching a consultation on medical device regulation, as well as establishing a work program for software and artificial intelligence (AI), the UK Medicines and Healthcare Products Regulatory Agency has advanced its efforts to create a post-Brexit regulatory environment.
Since the EU’s Medical Device Regulation was not implemented in the UK before the Brexit transition period ended, the UK will develop its own regulatory strategies for the medical devices industry.
A new approach to regulation has already been laid in the Medicines and Medical Devices Act 2021,
informed by the findings of the independent Cumberlege Review, and MHRA plans to use its new powers to amend UK regulations surrounding medical devices.
To gather feedback on the proposals, the government released a consultation document that contains 17 chapters. The document covers every aspect of medical device regulation in the UK, with one chapter addressing how medical devices are classified.
A medical device in UK is classified into Class I, IIa, IIb, or III, depending on its risk level. MHRA has decided to assign separate risk categories to a few devices while retaining the basic structure.
The chief executive of the MHRA, Dr June Raine, says:
“The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart.
We know that a problem with a medical device can have a significant impact on people’s lives. This consultation offers a once in lifetime chance to
help shape the regulations. In order to reach this goal, we want to hear from a wide range of people.
Delivering for patients is central to our work and we fully recognise the importance of the public
and patients’ perspectives and encourage them to share their views during this consultation. From pacemakers to contact lenses, wheelchairs to pregnancy tests, medical devices play a vital role for the vast majority of us and I encourage everyone who wants to be a part of this mission to put
forward their views.”