Independent report

Regulatory Horizons Council report on medical devices regulation

An independent report to government from the Regulatory Horizons Council about the regulation of medical devices.

• From: Department for Business, Innovation, Science and Trade, Department for Science, Innovation and Technology, Regulatory Horizons Council and Department for Business, Energy & Industrial Strategy
• Published: 19 August 2021

Documents

Regulatory Horizons Council report on medical devices regulation

PDF, 512 KB, 41 pages

Appendix A: opportunities and risks around future UK regulatory reform of medical devices

PDF, 11.5 MB, 19 pages

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Appendix B: lessons learned from COVID-19 in relation to IVD regulations

PDF, 13.5 MB, 19 pages

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Appendix C: alternative routes to market for medical devices

PDF, 11 MB, 17 pages

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Appendix D: mitigations for the move to the UKCA mark from 1 July 2023

PDF, 9.39 MB, 17 pages

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Details

The Regulatory Horizons Council (RHC) is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction.

This report makes recommendations on how the UK can encourage international investment, innovation and improve safety in the medical devices area through regulatory and non-regulatory changes.

Read the government response to the report.

Published 19 August 2021