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

14 May 2013 | Medical devices expert vacancies at the European Commission

The European Commission is looking for medical devices experts with at least six years of professional experience to work on policy, audits, inspections, and evaluation.

09 Apr 2013 | Public consultation on Medical Devices (Amendment) Regulations 2013

The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling.

04 Apr 2013 | MHRA response to the public consultation on the revision of European legislation on medical devices

The MHRA has published its analysis of the evidence received from healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices.

Go to the news and hot topics page

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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.

Go to the page on compliance with devices regulations

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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.

Go to the page on vigilance and adverse event reporting

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Contacting the MHRA

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

Go to the MHRA contact details for devices.

Guidance and policy

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

Go to the page on guidance and policy

Legislation

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

Go to the page on legislation

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).

Go to the page on surveillance and enforcement

Page last modified: 06 January 2012