Closed consultation

Consultation on the future regulation of medical devices in the United Kingdom

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Summary

We're looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future.

This consultation was held on another website.

This consultation ran from
to

Consultation description

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 United Kingdom (UK). We want to develop a future regime for medical devices which enables:

  • Improved patient and public safety;
  • Greater transparency of regulatory decision making and medical device information;
  • Close alignment with international best practice, and;
  • More flexible, responsive and proportionate regulation of medical devices.

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.

To share your views on this consultation complete the online survey

Patient and public responses

The consultation survey is wide ranging and all chapters may not be relevant for everyone – you have the option to select the chapters to respond to. If you are not a professional directly in the field of medical devices, you may be interested in the following few chapters.

  • Chapter 1 - covers the scope of the regulations and the products included. For example, cosmetic contact lenses, often used in fancy dress and are worn in the same way as prescription contact lenses, are currently not in scope of the regulations.
  • Chapter 13 - is about environmental sustainability and public health impacts, this includes the raw materials used and the recycling or disposal of medical devices.
  • Chapter 17 - was written with the general public in mind. If you have limited time to spare, have less experience of or limited interest in medical devices, you may prefer to complete this chapter.

Consultation webinars

We held two webinars which set out some background to this consultation – one aimed at industry, and one aimed at the wider public.

5 October 2021 - webinar aimed at industry –Webinar recording – Industry 5 October 2021

14 October 2021 – webinar aimed at patients and the wider public – Webinar recording - Public 14 October 2021

For any enquiries about the consultation, please contact futuredevicesregulations@mhra.gov.uk.

Documents

Cover Page

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Ministerial Foreword

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Executive Summary

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Introduction

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Information for Respondents

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Overview of Contents

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Medicines and Medical Devices Act 2021 Assessment

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Data Protection and Privacy Information

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Devices Regulation - Background

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Chapter 1: Scope of the Regulations

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Chapter 2: Classification

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Chapter 3: Economic Operators

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Chapter 4: Registration and UDI

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Chapter 5: Approved Bodies

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Chapter 6: Conformity Assessment

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Chapter 7: Clinical Investigation / Performance Studies

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Chapter 8: Post-market Surveillance and Vigilance

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Chapter 9: In vitro Diagnostic Medical Devices

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Chapter 10: Software as a Medical Device

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Chapter 11: Implantable Devices

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Chapter 12: Other Product-Specific Changes

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Chapter 13: Environmental sustainability and public health impacts

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Chapter 14: Routes to market

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Chapter 15: Transitional Arrangements

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Chapter 16: Feedback

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Chapter 17: Questions for members of the general public

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Appendix

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Glossary

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Published 16 September 2021
Last updated 26 October 2021 + show all updates
  1. Updated the relevant lines under the section on 'Consultation webinar', for the recording of the webinar for the Public on 14 October 2021.

  2. Added section - 'MHRA consultation on future medical devices regulations in the UK webinar recordings'

  3. Updated to say that two webinars have been hosted about the medical devices consultation.

  4. Added two webinars that will provide more background to the consultation

  5. First published.