90 385 cee pdf download

The guidelines have been carefully drafted through a process of intensive. Ce marking for a medical device lne gmed answers your. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90 385 eec and 9342eec. Direttiva 90 385 cee del consiglio, del 20 giugno 1990, per il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi medici impiantabili attivi. The procedures carried out by imq and the related assessment procedure are described in the imq regulation for the certification of active implantable medical devices ce marking directive 90 385 cee as amended available in the download section herein on the right. This document is meant purely as a documentation tool and. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Direttiva 90385cee del consiglio, del 20 giugno 1990. The active implantable medical devices directive with the official reference number 90 385 eec applies only to active implantable devices. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec. Directive 90385eec aimdd active implantable medical.

Secondo iallcgato 3 della direttiva europea 90 385 cee e successive modifiche attuate con dlgs. Directive 90 385 cee du conseil, du 20 juin 1990, concernant le rapprochement des legislations des etats membres relatives aux dispositifs medicaux implantables actifs journal officiel n l 189 du 20071990 p. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on. The new european medical device regulation 2017745.

A guide for manufacturers and notified bodies under directives 9342eec and 90 385 eec note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. Chapter i scope, placing on the market and free movement article 1 1. Ec no 12232009 and repealing council directives 90 385 eec and 9342eec. Understand all the elements needed for the technical documentation to address the requirements of directives 9342eec and 90 385 eec. For a device to be classified as an active implant, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain. Here is the direct link to mdr english version html with toc. Directive 90 385 eec aimdd active implantable medical devices directive check free resources major european regulations. Pdf the new european medical device regulation 2017745. Reporting of design changes and changes of the quality system.

Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Active implantable medical devices directive 90385eec. Medical devices 9342cee and active implantable medical. Ce marking directive 90385cee as amended available in the download. Management system certification is the endorsement enjoyed by organisations that have chosen to equip themselves.

Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices oj no l 189 of 20 july 1990. Use the following index to navigate into the different sections of the directive. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec oj l189 of 20 july 1990 this consolidated text has been prepared by commission services on the basis of the above directives amending directive 90 385 eec. Regulations for active implantable medical devices aimd under the eu directive 90 385 eec an active implantable medical device aimd is any active medical device that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes, and. Active implantable medical deivce directive aimdd 90385eec the active implantable medical. Identify and analyze hazards of product, process, or service. The active implantable medical device aimd directive 90 385 eec defines an active implantable medical device as any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. Iso 14971 risk management applied to medical devices. Get a quote for certification of systems, products or services, and get certified. Active implantable medical devices directive ce marking. Right click on the link below to download to your computer select save target as. You can download these guides from the european commission website. Active implantable medical devices directive 90385eec try it for free on. The ce marking directive 9368eec ce marking association.

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. Tuv sud offers testing services required under the european union aimd directive, 90385eec, including the auditing of a manufacturers quality system. Whereas council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 3 is the first case of application of the new approach to the field of medical devices. Active implantable medical devices directive 90385eec tuv sud.

If you prefer the html with toc version just look into the hmtl column ans select the version for your native language. Download from the link below the mdr in the main european languages. Direttiva 90 385 cee del consiglio, del 20 giugno 1990, per il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi medici impiantabili attivi gazzetta ufficiale n. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec oj l 189, 20. Reporting of design changes and changes of the quality system page 39 in some cases, the nature of the modification that must be reported is described in the regulation md incorporating. Council directive 9342eec of 14 june 1993 concerning medical devices. Ce marking ce mark for appliances burning gaseous fuels. Sede di roma zona eur via castelrosso 16 00144 roma. Directive 90385eec as amended relating to active implantable medical.