Ministerial Foreword
Updated 26 June 2022
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This consultation, on the future regulation of medical devices, comes at a fitting moment. Anyone reading the report of Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review can be left in no doubt about the importance of this issue.
When it comes to the safety of the medical devices we use, we can and must do better. As well as this, our departure from the European Union has provided us with a newfound regulatory freedom and a unique chance to reshape our rules.
COVID-19 has brought our life sciences industry into a completely different age. From developing our diagnostics infrastructure, to spearheading global genomic sequencing efforts, it is no exaggeration to say that the UK life sciences sector has dramatically changed the course of this pandemic – and demonstrated what we’re truly capable of.
Medical devices have been at the heart of this transformation. The huge effort to validate tests for COVID-19 has led to incredible advances in how we use in-vitro diagnostic medical devices, known as IVDs; while our ventilator challenge has shown that we can confront difficult problems by bringing together the best minds in manufacturing, innovation and regulation.
We also have a unique chance to build on the enormous leaps in software and artificial intelligence (AI) which we know have the capacity to transform healthcare for the better in the years ahead, through quicker diagnostics, faster treatments and better tools for clinicians. We must shape the smart regulation that helps us achieve this, and give clear guidance that ensures patient safety.
I’m grateful to the MHRA for everything they have done to get us to this point – and for running this consultation. Through the pandemic, they have shown themselves to be one of the world’s foremost regulators – and true innovators. I’m excited by their capabilities and what they will help make possible in a post-pandemic world.
This consultation reflects the lessons learned in recent years and provides a platform from which we can build something truly remarkable: a life sciences sector that continues to lead the world and safeguard and advance the health of our nation. I encourage everyone who wants to be a part of this mission to put forward their views.