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:
- investigating allegations received about possible non-compliance with the regulations
- 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
03 Feb 2012 | Medical Device Technology Forum on hip implants
An orthopaedic workshop, held on 4 November 2011, explored the difficulties in promoting innovation in the orthopaedic field while maintaining patient safety.
30 Jan 2012 | Poly Implant Prothese (PIP) breast implants update
Women concerned about PIP breast implants can find all the latest NHS information on NHS Choices.
24 Jan 2012 | Department of Health sets out scope of PIP implant and cosmetic surgery reviews
The Department of Health has today published the terms of reference for two reviews established following the recent concerns about PIP implants.
Compliance with devices regulations
Vigilance and adverse event reporting
Contacting the MHRA
Guidance and policy
Legislation
Surveillance and enforcement
