Devices industry

Welcome to the devices industry area of the MHRA website. This section provides targeted links to information throughout the site that is relevant to manufacturers of medical devices.

The MHRA is the competent authority (CA) for the UK. On behalf of the Secretary of State for Health, we administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales. The MHRA meets its CA functions in the following ways:

  • Enforces the regulations by:
    1. investigating allegations received about possible non-compliance with the regulations
    2. operating a proactive inspection programme where manufacturers are randomly selected for inspection by MHRA's own staff.
  • Designates UK notified bodies and audits them.
  • Investigates post-market surveillance reports received from medical device manufacturers and users.
  • Maintains a register of certain types of manufacturers.

If you have any feedback on this section and how we can improve it please email webusability@mhra.gsi.gov.uk or fill out our feedback form.


News and hot topics

19 Mar 2014 | Medical device stand-alone software (including apps)

The MHRA has today published guidance on medical device stand-alone software (including apps).

30 Jul 2013 | Proposal for new European regulations aimed at improving consumer product safety and the functioning of the European internal market through market surveillance

The Department for Business Innovation and Skills (BIS) have published a consultation seeking views on the European Commission's proposals for two new European device regulations.

01 Jul 2013 | Business Engagement Assessment about EC Regulation on e-labelling of medical devices

The MHRA seeks your views on the EC Regulation on electronic instructions for use of medical devices.

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Compliance with devices regulations

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This page provides links to information about compliance with device regulations. This includes clinical trials for devices, custom-made devices and dental laboratories.
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Vigilance and adverse event reporting

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This section sets out how the MHRA monitors the safety of devices and gives all the relevant information on reporting adverse incidents involving medical devices, including details on the updated online reporting system. It also provides the obligations on manufacturers for reporting adverse incidents and field safety corrective actions to the MHRA.
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Contacting the MHRA

Telephone
This page provides links to information about how to contact the MHRA.

Guidance and policy

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This section provides links to guidance and policy related to the regulation of medical devices.

Legislation

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This section provides links to details of the legislation relating to the manufacture, sale and supply of medical devices.

Surveillance and enforcement

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This section provides links to information about how we ensure that medical devices placed on the UK market are compliant with the Medical Device Regulations 2002 (as amended).
Page last modified: 06 January 2012