Council directive 93 42 eec of 14 june 1993 concerning medical devices. The medical device directive is intended to harmonise the laws relating to medical devices. Council directive 9342eec of 14 june 1993 concerning. Medical devices directive 9342eec requirements for. B council directive 9342eec of 14 june 1993 concerning. Normally intended for continuous use for more than 30 days. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Council directive 9342eec of 14 june 1993 concerning medical devices. Medical device directive 9342eec cemarking qnet, llc. Commission directive 200312ec of 3 february 2003 on the reclassification of breast implants in the framework of directive 93 42 eec concerning. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.
Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. The manufacturer has an eu medical device directive mdd full quality. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices. Conformity with medical device directive 9342eec is mandatory all. Medical devices directive 9342eec breathing system filters for anaesthetic and respiratory use part 2. Council directive 9342eec on medical devices mdd 1993. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. Mds 7003 medical devices incorporating derivates of human blood, according to directive 200070ec, amended by directive 2001104ec mds 7004 medical devices referencing the directive 2006 42 ec on machinery creation date. Directive 200070ec of the european parliament and of the council of 16 november 2000.
Download council directive 9342eec on medical devices mdd. Annex 9 directive 9342eec amended, concerning medical devices. F8 deleted by directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of. Medinfo medinfo council directive 9342eec on medical devices. Medical devices directive 9342eec pdf download 10yi83. The ivd directive was amended and corrected over time. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Commission directive 200312ec on the reclassification. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission.