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Welcome!

If you have not already done so, please refer to the consultation document, which explains what this consultation is about. The consultation closes at 11.45pm on 25 November 2021.

From contact lenses and COVID-19 test kits, to pregnancy tests and pacemakers, for many of us, medical devices are an essential part of our everyday lives. We all want to know that the devices we use are safe and effective, so regulation of medical devices really matters.

The Medicines and Healthcare products Regulatory Agency (MHRA) is working to develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.

The MHRA is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the UK.

We welcome the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our future approach to regulating medical devices in the UK.

This is an important opportunity to make a difference to how we regulate and experience medical devices – helping ensure that people have safe, quality, innovative medical devices which improve their lives.

Useful information for respondents

Before you begin, please review the information on the consultation launch page on gov.uk here before you complete this survey, including a data protection and privacy information statement.

You should also note:

  • Access helpful information – as you complete the survey you will be able to access (via links at the bottom left of the screen) all sections of the consultation, the glossary and a section on current definitions in the UK medical devices regulations.
  • Save your responses - when completing the survey, each time you click ‘Next’ at the end of a page, your response to the consultation so far will be saved. If you wish to take a break and return to the consultation later, you can do this by returning to the url in your browser (you might wish to copy it to use later!). You can do this as many times as you need to until you press ‘Submit’ at the end of the consultation. When you press ‘Submit’, your response will be closed and submitted.
  • Edit your responses - if you wish to edit any of the responses you have given, you can do this at any point before you press ‘Submit’. You can do this by navigating to the relevant page of the consultation (using the back button or by clicking on ‘Show all sections' at the bottom of the screen and going into the relevant section).
  • Change the range of sections you are completing – you can add to the number of sections you opt to complete answers to at any time – simply click on the ‘Show all sections’ link at the bottom left of the screen, select ‘Areas of consultation’ and add to the number you have selected in response to that question.
  • Contact us if you have any trouble accessing the online survey at futuredevicesregulations@mhra.gov.uk.
  • Word counts – in most cases free text answers are limited to 2500 characters (approx. 250 words).
  • Website links – these won’t open in a separate tab unless you select to (when right clicking on the link). You will need to press ‘back’ to return to the survey.

You may also be interested in attending or viewing our webinars about this consultation – you can find more information about these in this consultation announcement. Any outstanding enquiries about the consultation can be directed to: futuredevicesregulations@mhra.gov.uk.