§ Tim LoughtonTo ask the Secretary of State for Health what steps he has taken to publicise new regulations requiring CE marking on packaging for self-testing diagnostic medical devices. [88528]
§ Mr. LammyThe Medical Devices Agency (MDA), which is the United Kingdom's competent authority for the medical devices regulations, has published the In Vitro Diagnostic Medical Devices Directive, which came into force on 7 June 2000, on its web site together with guidance documents on its implementation. In addition members of the MDA have given several presentations on the Directive's provisions to both manufacturers and users.