Collection
Regulatory guidance for medical devices
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
COVID-19 medical devices guidance
- Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
- Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak
- Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
- Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
- Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
Documents
- Custom-made medical devices
- Devices which incorporate an ancillary medicinal substance
- Electronic instructions for use of medical devices: guidance on regulations
- Exceptional use of non-CE marked medical devices
- In vitro diagnostic medical devices: guidance on legislation
- Medical devices: how to comply with the legal requirements
- Medical devices: off-label use
- Medical devices: software applications (apps)
- Medical devices: UK notified bodies
- Medical devices regulations: compliance and enforcement
- Virtual manufacturing of medical devices
- Notified bodies for medical devices
- Notify MHRA about a clinical investigation for a medical device
- Regulation of IVDs for self-testing
Published 18 December 2014
Last updated 31 March 2020 + show all updates
Last updated 31 March 2020 + show all updates
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Added a new section on COVID-19 medical devices guidance
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Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
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Added a link to Medical devices: how to comply with the legal requirements guidance.
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Added new document on devices which incorporate an ancillary medicinal substance
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First published.