Direttiva 9342cee marcatura ce dei dispositivi medici. At the moment the new directive is not mandatory, it has. Directiva 9342cee a consiliului din 14 iunie 1993 privind dispozitivele medicale. Directive 9342cee et modification successive 200747ce. Overview a medical device is defined in directive 93 42 eec as. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards.
The social cost of the large number of accidents caused by the use of machinery can be reduced by. Council directive 9342eec of 14 june 1993 concerning medical. Medical devices internal market, industry, entrepreneurship. Council directive 9342eec of 14 june 1993 concerning medical devices. Directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. Jan 30, 2008 finally the consolidated version of the revision of the medical device directive 93 42 eec is published on the eurlex server i have attached the english, french and spanish version other languages are available at the above link. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. The content of this page deals only with the medical devices directive 93 42 eec. Mdd 9342ec, annex ii ec design examination certificate.
Because of the many types of devices covered by the mdd, the specific requirements depend on the. Understanding the machinery directive 2006 42ec the directive has been put in place because. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to. Directive 9342cee du conseil, du 14 juin 1993, relative aux. The references published under directive 93 42 eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below.