Guidance: Medical devices regulations: compliance and enforcement | GovWire News

Guidance: Medical devices regulations: compliance and enforcement

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Medicines Healthcare Products Regulatory Agency

May 17

12:14 2023

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Medical devices: the regulations and how we enforce them

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Report a non-compliant or suspected counterfeit medical device

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Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

MHRA has the responsibility to check that medical devices in the UK comply with legal requirements.

This guidance includes:

contact details to report a non-compliant medical device
information on MHRAs enforcement duties after receiving a complaint
MHRAs routine monitoring role
the manufacturers rights if they have received an enforcement notice

Published 18 December 2014
Last updated 17 May 2023 +show all updates

17 May 2023
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
26 February 2019
Added a link to new guidance on medical devices regulation in a no deal scenario.
24 March 2017
Change in penalty from fine up to 5,00 per offence to an unlimited fine.
1 March 2017
Page title changed and new document added to the page to replace 'RAMS'
18 December 2014
First published.

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