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 four sets of Medical Device Regulations implementing all of the Medical Devices Directives and amendments to date; Statutory Instruments 2002 No. 618 (Consolidated legislation), 2003 No. 1697 (Amendments to cover the re-classification of breast implants and additional requirements covering devices utilising materials from TSE susceptible animal species), Medical Devices Regulations 2007 No. 400 (Amendment to cover the re-classification of total hip, knee and shoulder joints) and the Medical Devices (Amendment) Regulations 2008 No 2936 which transpose Directive 2007/47/EC into UK law, were passed by Parliament in December 2008 and fully come into force in March 2010. They have been issued under the Consumer Protection Act and can be found on the Office of Public Sector Information (OPSI) (external link) website.

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