How we regulate devices

The Regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.

There are currently two sets of Medical Device Regulations implementing all of the Medical Devices Directives and amendments to date; Statutory Instruments 2002 No. 618 (Consolidated legislation) and 2003 No. 1697 (Amendments to cover the re-classification of breast implants and additional requirements covering devices utilising materials from TSE susceptible animal species). They have been issued under the Consumer Protection Act and can be found on the Office of Public Sector Information (OPSI) website.

Other useful information can be found on the European Commission's website covering the medical devices sector.


Page last modified: 17 August 2007