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Statutory Instruments are the key form delegated or secondary legislation (law) is made in Great Britain. The process of creating of Statutory Instruments is governed by the Statutory Instruments Act 1946.

There are currently four sets of Medical Device Regulations implementing all of the European Community Medical Devices Directives and amendments to date.  These regulations place obligations on manufacturers to ensure that devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.  These Medical Device Regulations are:

  1. Statutory Instruments 2002 No. 618 (Consolidated legislation),
  2. 2003 No. 1697 (Amendments to cover the re-classification of breast implants and additional requirements covering devices utilising materials from TSE susceptible animal species),
  3. Medical Devices Regulations 2007 No. 400 (Amendment to cover the re-classification of total hip, knee and shoulder joints), and the
  4. 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 Legislation.gov.uk (external link) website. 

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.  More information on the Statutory Instruments regulating medical devices can be found on the MHRA website.

Last updated: 20 July 2017