Council directive 90496eec on nutrition labelling of foodstuffs provides for the possibility of amending specific aspects of the legislation via the standing committee procedure. 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. Furthermore it is important that the clinical investigation plan correctly reflects the clinical evaluation as planned by the manufacturersponsor. 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. Table of contents european medical device regulation. Directive 90385eec on active implantable medical devices the directive 90385eec covers the placing on the market and putting into service of active implantable medical devices. This document is available in either paper or pdf format.
The amendments introduced by directive 9342eec are indicated in bold, the amendments following directive 9368eec are in italic. Active implantable medical devices internal market. Oct 11, 2007 90385eec 2007 active implantable medical device directive. Table of contents european medical device regulation 2017745. The regulation of medical devices in the european union. Guidelines to the application of the council directive 90385eec on active implantabl 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.
Regulation eu 2017745 of the european parliament and of. Active implantable medical devices directive 90385eec tuv. 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. 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. The amendments introduced by directive 9342 eec are indicated in bold, the amendments following directive 9368 eec are in italic. The active implantable medical device directive aimdd 90385 eec effective june 20, 1990 states that all active implantable medical device manufacturers must acquire cemarking to be able to put their products on the european market. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. 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. The references published under directive 90385eec on active implantable medical devices are found in commission implementing decision eu 2020438 of 24 march 2020 oj l 90i, 25 march 2020 listed below. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof. The active implantable medical devices directive with the official reference number 90385eec applies only to active implantable devices. The active implantable medical devices directive with the official reference number 90 385 eec applies only to active implantable devices.
Council directive 90385eec 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. Active implantable medical devices directive 90385eec medical devices application of risk management to medical devices iso 14971. To demonstrate compliance with the requirements of the aimd directive, a manufacturer must develop technical documentation in order to properly evaluate their. Directive 90385eec or section 2 of annex x of directive 9342eec. New european regulation for medical devices to replace.
Ce marking ce mark for appliances burning gaseous fuels. B 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 9342 eec text with eea relevance oj l 117, 5. Council directive 9368eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction products, 89336eec electromagnetic compatibility, 89392eec machinery, 89686eec personal protective equipment, 90384eec nonautomatic weighing instruments, 90385eec active. The references published under directive 90 385 eec on active implantable medical devices are found in commission implementing decision eu 2020438 of 24 march 2020 oj l 90i, 25 march 2020 listed below.
Directive 90385eec on active implantable medical devices directive 9342eec 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. Official journal no page date m1 council directive 9342 eec of 14 june 1993 l 169 1 12. Commission communication in the framework of the implementation of the council directive 90385eec 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. Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices. This document is meant purely as a documentation tool and. Ce marking for european directives the language center. Council directive 90385eec 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 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 90 385 eec aimdd active implantable medical devices directive pdf check free resources major european regulations tip. 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 try it for free on. Directive 90496eec on nutrition labelling for foodstuffs. As of 21 march 2010, certificates issued in accordance with annex 5 of directive 90 385 eec and annexes v and vi of directive 9342 eec need to be limited in time max.
Directive of active implantable medical devices 9879ec. The active implantable medical device aimd directive 90385eec 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. Active implantable medical devices directive 90385eec biological evaluation of medical devices part 1. Whilst the commission continues to reflect on some of the more fundamental issues related to the revision of this directive, it has been decided. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90385eec. 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. Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices.
Council directive 9342 eec of 14 june 1993 concerning medical devices. Active implantable medical devices directive 90 385 eec biological evaluation of medical devices part 1. 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. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om. Spanish, danish, german, greek, english, french, italian, dutch, portuguese, icelandic, norwegian. B 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 90385eec and 9342eec text with eea relevance oj l 117, 5. 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 90385eec and 9342eec text with eea relevance. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec oj l 189, 20.
Active implantable medical device a product falls within the field of application of the directive if it complies with the definition given in this. Council directive 90314eec of june 1990 on package. Directive 90385eec 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. The aimd 90385 eec also mentions the language requirement issue in article 4.
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. Council directive of 20 june 1990 on the approximation of the. Evaluation and testing within a risk management process iso 109931. Search for an harmonised standard using the most powerful standard search engine on the web. Active implantable medical devices directive 90385eec tuv sud. Environmental design for energyrelated products directive 2009125ec. As of 21 march 2010, certificates issued in accordance with annex 5 of directive 90385eec and annexes v and vi of directive 9342eec need to be limited in time max. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12.
The ce marking directive 9368eec ce marking association. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec. Products, for which these conformity assessment procedures have been used and which have not yet been placed on the market andor put into service before 21. B council directive 9342eec of 14 june 1993 concerning. You can find all the info you need by filtering by directive, andor enabling or disabling the synonyms search. Active implantable medical devices directive 90 385 eec medical devices application of risk management to medical devices iso 14971. Active implantable medical devices directive 90385eec. Directives 90385eec and 9342eec medical devices clinical. Council directive 9368eec of 22 july 1993 amending. Directive 90385eec of the european union eu specifies the essential requirements manufacturers and importers must meet to apply the ce mark and legally. Click on the arrow on the right corner to scroll up.
Council directive of 20 june 1990 on the approximation of. This document is meant purely as a documentation tool and the. Directive 90 385 eec on active implantable medical devices the directive 90 385 eec covers the placing on the market and putting into service of active implantable medical devices. Directive 9879ec on in vitro diagnostic medical devices ivds. Council directive of june 1990 on package travel, package holidays and package tours 90314eec 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. Active implantable medical devices directive ce marking. Directive 84539 eec, directive 90 385 eec current legislation the medical device directive council directive 9342 eec of 14 june 1993 1 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. Guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec. 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 other references of standards published in the commission communication 2017c 38902 5 should therefore also be included in this decision. 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. Directive 90385eec on active implantable medical devices. Annex 1 to directive 90385eec and annex i to directive 9342eec, respectively, set out the essential requirements that active implantable medical devices and other medical devices must meet in.
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