Consultation outcome

Ministerial Foreword

Updated 26 June 2022

The past few years have been a time of great change for medical devices. The UK’s decision to leave the EU has presented a great opportunity to build our own regulatory regime, whereas the Covid-19 pandemic has seen huge advances in the life sciences and diagnostics.

We are well placed to succeed in this mission. We have a dynamic and pioneering MedTech sector, along with the MHRA’s established track record of innovation-friendly regulation, who are renowned as one of the world’s most effective regulators.

We will be launching the UK’s inaugural MedTech strategy soon; and the plans in this consultation show the steps we are taking to deliver improved patient and public safety, greater transparency, and more proportionate regulation of medical devices.

I am also determined to eradicate bias, however inadvertent, when it comes to medical devices, and I have appointed Dame Margaret Whitehead to establish the extent of this issue and recommend what action can be taken.

I am grateful to everyone who has shared their views as part of this consultation, including patients, industry and the healthcare sector. Your input has been invaluable in helping us to shape the future of medical devices in the UK, and I am delighted that our plans for a step-wise, prioritised transition to these new regulations have been overwhelmingly supported.

We have a plan to build on the breakthroughs of the past few years, supporting this country’s pioneers while keeping us all safe. Now, we must put it into action.

Sajid Javid, Secretary of State for Health and Social Care