Ndirective 90 385 eec pdf

Use the following index to navigate into the different sections of the directive. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the. This document is meant purely as a documentation tool and. This document is available in either paper or pdf format. Active implantable medical devices internal market, industry. Directive 90385eec of the european union eu specifies the essential requirements manufacturers and importers must meet to apply the ce mark and legally. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them.

Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020 date of application to meet the requirements of the mdr. Whilst the commission continues to reflect on some of the more fundamental issues related to the revision of this directive, it has been decided. Directive 90385 eec on active implantable medical devices aimdd, annex 2 excluding 4. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission. Council directive 9368eec of 22 july 1993 amending. Council directive 90 496 eec on nutrition labelling of foodstuffs provides for the possibility of amending specific aspects of the legislation via the standing committee procedure. Directive 9368 eec ce marking directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90 385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342 eec concerning medical devices and directive 988ec. Directive 90 385 eec or section 2 of annex x of directive 9342 eec. Directive 9879ec on in vitro diagnostic medical devices ivds. Ce 0051 certification to commercialise medical devices and active implantable medical devices in europe. Regulations for active implantable medical devices aimd under the eu directive 90 385 eec.

The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md. Active implantable medical devices directive 90385eec. Council directive 9342 eec of 14 june 1993 concerning medical devices. To demonstrate compliance with the requirements of the aimd directive, a manufacturer must develop technical documentation in order to properly evaluate their. 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 this document comes with our free notification service, good for the life of the document. 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 the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the. Council directive of 20 june 1990 on the approximation of. Council directive of june 1990 on package travel, package holidays and package tours 90 314 eec the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1. Directive 90385eec on active implantable medical devices. 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. The amendments introduced by directive 9342 eec are indicated in bold, the amendments following directive 9368 eec are in italic.

Certificate eu directive 90385eec location zwonitz pdf, 629 kb. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90 385 eec. 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 7 is the first case of application of the new approach to the field of medical devices. Directive 90 385 eec the european commission, having regard to the treaty on the functioning of the european union, having regard to regulation eu no 10252012 of the european parliament and of the council of 25 october 2012 on european standardisation, amending council directives 89686 eec and 9315 eec and directives 949ec, 9425ec.

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. Regulation eu 2017745 of the european parliament and of. Directive 90385eec on active implantable medical devices aimdd, annex 2 excluding 4. Official journal no page date m1 council directive 9342 eec of 14 june 1993 l 169 1 12. The regulation of medical devices in the european union. 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 which is intended to remain in place. 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. Save my name, email, and website in this browser for the next time i comment. Council directive 90385eec medical device regulation. Guidelines relating to demarcation between directive 90. New european regulation for medical devices to replace 93. The active implantable medical devices directive has a a first objective the harmonisation of the regulatory environment across the european economic area, and. Directive 90385eec aimdd active implantable medical.

There are three medical device directives in place, the directive of active implantable medical devices 90 385 eec, the medical devices directive 9342 eec, and the directive of in vitro diagnostic medical devices 9879ec. Complete quality assurance system according to ec directive 90 385 eec raumedic is manufacturing in a controlled environment manufacturing processes such as the production of medical products or semifinished medical products and of pharmaceutical products as well place high demands on the environmental conditions. 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. Active implantable medical devices directive 90 385 eec biological evaluation of medical devices part 1. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Click on the arrow on the right corner to scroll up. To demonstrate compliance with the requirements of the aimd directive, a manufacturer must develop technical documentation in order to properly evaluate their device. 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 l 189, 20.

Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices. Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Directive 90 385 eec aimdd active implantable medical devices directive check free resources major european regulations. Active implantable medical devices directive 90 385 eec. Medical devices technologies active implantable medical. Council directive 90 385 eec home posts tagged council directive 90 385 eec massimop z annex 17 xvii correlation table annex, annex xvii, article, correlation table, council directive 90 385 eec, council directive 9342 eec, mdr annex xvii. Provisions of directive 200747ec directive 200747ec amends directive 90 385 eec on active implantable medical devices and directive 9342 eec on medical devices. Council directive 9368 eec of 22 july 1993 amending directives 87404 eec simple pressure vessels, 88378 eec safety of toys, 89106 eec construction products, 89336 eec electromagnetic compatibility, 89392 eec machinery, 89686 eec personal protective equipment, 90 384 eec nonautomatic weighing instruments, 90 385 eec active. Council directive 90314eec of june 1990 on package. Commission communication in the framework of the implementation of the 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 text with eea relevance publication of titles and references of harmonised standards under the directive 20c 2201 eso 1.

Active implantable medical devices directive ce marking. The active implantable medical devices directive with the official reference number 90 385 eec applies only to active implantable devices. 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. The ce marking directive 9368eec ce marking association. 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 official journal l 189, 20071990 p. Directive 90 385 eec on active implantable medical devices directive 9342 eec on medical devices directive 9879ec on in vitro diagnostic medical devices ivds same rules applied for the whole eu transposed into national legislation free circulation of medical devices within the eu. Furthermore it is important that the clinical investigation plan correctly reflects the clinical evaluation as planned by the manufacturersponsor. Medical devices can be placed on the market or put into service only if they meet the requirements of directive 9342 cce and of the directive 90 385 eec and as amended which are intended to ensure the safety and health protection of patients, users. Directive 9342eec as amended concerning medical devices. Directive 90 385 cee du conseil, du 20 juin 1990, concernant le rapprochement des legislations des etats membres relatives aux dispositifs medicaux implantables actifs.

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. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Table of contents european medical device regulation. Directive 90496eec on nutrition labelling for foodstuffs. Directive 90 385 eec of the european union eu specifies the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell aimds in the eu.