Directive 90270eec display screen equipment latest update. On the one hand, however, the scope is extended to some products currently not covered by the aimddmdd. The conditions for the use of active implantable medical devices in clinical research. Council directive 9342eec of 14 june 1993 concerning medical devices. Introduction directive 90 384eec was adopted on 20 june 1990 and came into force on 1 january 1993. 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. 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. M1 direttiva 941ce della commissione del 6 gennaio 1994 l 23 28 28.
Directive 90385eec on active implantable medical devices. Community rules applicable to all medical devices, this directive is based largely on the provisions of directive 90 385 eec. While this directive applies in all member states of the european union, each member state has its own way of implementing the directive within their country, essentially adding regulations to the directive and creating local legislation. Council directive 90314eec of june 1990 on package.
Directive 200183ec and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the methods specified in annex 1 to directive 200183ec. Active implantable medical devices directive 90385eec tuv sud. Click on the arrow on the right corner to scroll up. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385.
This directive includes specific requirements related to pressure hazard and flammability as well as a general obligation to analyse all hazards which could apply to an aerosol dispenser product. Directive for active implantable medical devices 90 385 eec directive for medical devices 9342eec directive on in vitro diagnostic medical devices 9879ec. The directive concerns all nonautomatic weighing instruments and is total in application. Rohs 2 directive toy safety directive erp directive energy related products marine equipment directive replaced by directive 201490eu mandatory as of 18 september 2016 ppe directive personal protective equipment ppe 2004108ce 201453ue 200695ce 200642ce 9409ce 200747cee 9879ce 90 385 cee 200422ce 201165ue 200948ce. Active implantable medical devices internal market. Council directive 90385eec of 20 june 1990 on the approximation of the. Directive 90269 eec manual handling of loads latest update. Ce marking ce mark for appliances burning gaseous fuels. Directive 90270eec display screen equipment safety.
Directive 90385eec of the european union eu specifies the essential requirements manufacturers and importers must meet to apply the ce mark and. As an aimd notified body our product specialists can help you navigate the regulatory process to get. 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 changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Council directive 90429eec of 26 june 1990 laying down the. Evaluation of the aerosols dispensers directive 75324ec. Annex ii with the exception of point 4, v or vi of directive 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. 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. Energyrelated emissions of ozone precursors emissions of tofp in terms of nmvoc equivalent. Annex ii with the exception of point 4 and v of directive 90 385 eec. Provisions of directive 200747ec directive 200747ec amends directive 90 385 eec on active implantable medical devices and directive 9342eec on medical devices. May 27, 2006 ce tech file for the ce tech file, just read the suitable directive it will tell you what info you need to have. Whereas the electromagnetic compatibility aspects form an integral part.
The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. European medical device directive essential requirements. 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. 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 this directive has been amended by the following council directives. On 23 july 1990 the council of the european union adopted the original parentsubsidiary directive directive 90435eec. Directive 90385cee du conseil, du 20 juin 1990, concernant. Directive 90 270eec display screen equipment latest update. 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.
Directive 90270eec display screen equipment safety and. Working document on package travel directive 90314eec. Directive for active implantable medical devices 90 385 eec directive for medical devices 9342eec. Placing a medical device into the european market is contingent upon compliance with the medical device directive 9342eec. Council directive 90220eec of 23 april 1990 on the deliberate release into the environment of genetically modified organisms. As of 21 march 2010, certificates issued in accordance with annex 5 of directive 90 385 eec and annexes v and vi of directive 9342eec need to be limited in time max. The term ec mark or ce mark appeared in this directive is out of date and has been officially replaced by term ce marking in 1993 in the ce marking directive 9368eec. Cableway installations designed to carry persons 20009ec.
Reporting of design changes and changes of the quality system. Ce marking ce mark for active implantable medical devices. Directive 90269eec manual handling of loads safety. Council directive 90429eec of 26 june 1990 laying down.
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. Introduction directive 90384eec was adopted on 20 june 1990 and came into force on 1 january 1993. Directive 90385eec aimdd active implantable medical. 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 90 385 eec aimdd active implantable medical devices directive check free resources major european regulations. Direttiva 75324cee add aerosol direttiva del consiglio del 20 maggio 1975 per il ravvicinamento delle legislazioni degli stati membri relative agli aerosol 75324cee gu l 147 del 9. It was modified by directive 9368eec of 22 july 1993, with effect from 1 january 1995. B council directive 9342eec of 14 june 1993 concerning. 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. 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. This document is meant purely as a documentation tool and the. Council directive of 29 june 1990 on the approximation of the laws of the member states relating to appliances burning gaseous fuels 90 396eec this directive has been amended by the following council directives. It regards the approximation of the laws of the member states on measures to be taken against air pollution by emissions from motor vehicles. Directive 90219eec council directive 90219eec of 23 april 1990 on the contained use of genetically modified microorganisms oj no l 117 of 8.
Council directive 90220eec of 23 april 1990 european. 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. The regulation of medical devices in the european union. Active implantable medical devices directive 90385eec. Most of the provisions of this new regulation will be applicable as from 11 july 20 and replace the cosmetics directive 76768eec thereafter.
On 23 july 1990 the council of the european union adopted the original parentsubsidiary directive directive 90 435eec. The active implantable medical devices directive with the official reference number 90 385 eec applies only to active implantable devices. Council directive of june 1990 on package travel, package holidays and package tours 90 314eec 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. Journal of the european union on may 5, 2017, and entered into force on may 25, 2017. Pdf the new european medical device regulation 2017745. 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 of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices.
The new eu cosmetic products regulation, eu regulation ec no 12232009 fulltext, pdf was adopted on november 30, 2009. Directive of the european parliament and of the council of 5th 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 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal prodcuts on the. Evaluation of the aerosols dispensers directive 75324ec final report 2017 the aerosol dispensers directive add 75324eec is one of the oldest eu legislations related to product safety. 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. Council directive of 29 june 1990 on the approximation of the laws of the member states relating to appliances burning gaseous fuels 90396eec this directive has been amended by the following council directives. Reporting of design changes and changes of the quality system page 59 andor the requirements of the directive e. 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. Ce marking for a medical device lne gmed answers your. Ce tech file for the ce tech file, just read the suitable directive it will tell you what info you need to have. Directive 90269eec manual handling of loads safety and. Directive 90385eec defines the requirements of aimds. This frequently asked questions faq aims to provide. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90 385 eec.
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