Ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives. 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. 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. Evaluation of the aerosols dispensers directive 75324 ec. 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. 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. Evaluation of the aerosols dispensers directive 75324ec. Directive 90385eec aimdd active implantable medical. Directive 90 385 cee and directive 9342 cee, entered into force on 25 may 2017 and applies from 26 may 2020.
Directive 90270eec display screen equipment of 29 may 1990 on the minimum safety and health requirements for work with display screen equipment fifth individual directive within the meaning of article 16 1 of directive 89391eec. European medical devices directive 9342eec with 200747ec. 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. Note 4 this symbol corresponds to that given in iso 70002607 and to symbol no. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Necessity of consultation procedures on medical devices. Council directive 90 385 cee of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Ce marking and european medical device directive 9342cee. Council directive 9342eec of 14 june 1993 concerning medical devices. Necessity of consultation procedures on medical devices incorporating a medicinal substance 1 introduction medical devices are mainly regulated by three directives in the european union. It can be distinguished from regulations, which are selfexecuting and do not require any implementing measures. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Ce marking is currently required for many products sold in europe, yet many u.
Questions relating to the implementation of directive 200747 ec 1. Directive amended by directive 90488eec oj no l 270, 2. Date of directive directive 85374eec liability for defective products. Directive 85374eec liability for defective products. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of council directive 6565eec of 26 january 1965 on the approximation of provisions laid down by law. Council directive 90 385 eec on active implantable medical devices aimdd, council directive.
Directives normally leave member states with a certain amount of. Whereas council directive 90 385 eec of 20 june 1990. Directive 90 385 cee du conseil, du 20 juin 1990, concernant le rapprochement des legislations des etats membres relatives aux dispositifs medicaux implantables actifs. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Council directive 90314eec of june 1990 on package. Final report 2017 the aerosol dispensers directive add is one of the oldest eu legislations related to product safety. Active implantable medical devices directive 90385eec. Easily share your publications and get them in front of issuus.
Interactive web page allows for inpage navigation from section to section. Active implantable medical devices internal market. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. Eu council directive of 20 june 1990 90 385 eec brief introduction of. Working document on package travel directive 90314eec.
The batch code shall be adjacent to the symbol see a. Direttiva 90 385 cee del consiglio, del 20 giugno 1990, per il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi medici. Securing the free movement of aerosol dispensers throughout the eu. This document is meant purely as a documentation tool and. 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 by the manufacturer. The directive contains an exculpation clause for the producer e. The product is compliant with the specifications of the directive 9342cee contains phthalates dehp latex free single use device.
If your question is whether or not your product will need ce marking andor which eu directive may apply to your products, please. To do this, make sure it is kept free from any obstructions. A directive is a legal act of the european union which requires member states to achieve a particular result without dictating the means of achieving that result. Compose in few minutes declaration of conformity compliant with applicable directives.
Directive 90 385 eec aimdd active implantable medical devices directive check free resources major european regulations. 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. Search for a standard by keyword or synonyms or filtering by directive s. As such, member states must allow the marketing on their territory of aerosol dispensers that comply with the directive. A european regulation enters into force with mandatory. Click on the arrow on the right corner to scroll up. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to. Use the following index to navigate into the different sections of the directive. Meet our mdr team and get free educational resources on the mdr. 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 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal. Compliance of medical devices with the new requirements. 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.
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