Directive 93 42 eec download skype

Medical devices directive 93 42 eec pdf download 10yi83. Definitions the terms mineralextracting industries through drilling and workplace are defined. Directive as amended by directive 98 79 ec oj l 331, 7. The ce marking directive 9368eec ce marking association. Medical devices regulations 21st march, 2010 legal notice 210 of 2008. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. The revision of the medical devices directive 9342eec. Directive of medical devices 2001 guidelines for classification of medical devices guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec. As a notified body bsi can work with you to apply for ce marking, an essential trade passport which allows. Product placement on the market cannot be prevented by any eu country if a device caries a ce mark which is a confirmation that this device meets the basic requirements according to annex 3. Council directive 90385eec, council directive 9342eec and the mdr. Our quality management system is certified in accordance with din en iso 485.

June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Directive 98 37 ec remains in force until 29 december 2009. Sina weibo sitejot skype slashdot sms stocktwits svejo symbaloo. Product conformity assessment service for medical devices and other. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Please ensure your ship to address is able to receive your purchase. Directive 2006116ec of the european parliament and of the council of 12 december 2006 on the term of protection of and certain related rights codified version is the consolidated version of 9398ec with amendments that is in force since 2007. 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. Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. Council directive 9342eec of 14 june 1993 concerning. Classification criteria definitions for the classification. Council directive 9399eec of 29 october 1993 on the.

For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Medical devices directive mdd 9342eec with 200747ec consolidated version. Patent mn20u1 directive 9342eec medical devices directive 200642ec machinery directive directive 2004108ec emc electromagnetic compatibility european registered design no. Council directive 9315eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses description. The ivd directive was amended and corrected over time. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. 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. If you have downloaded the 175page european medical device. 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. If the device is intended to be used in combination with another device, the. Council directive 9312eec of 23 march 1993 relating to.

Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of iso 485. European medical device directive french translation. B council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs oj l 175, 19. There are three medical device directives in place, the directive of active implantable medical devices 90385 eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. Directive 9242eec covers the efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Directive 9368eec amending directives 89392eec machinery atex directives. Council directive 9342eec of 14 june 1993 concerning medical devices 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, in cooperation with the european parliament 2. Directive 9291eec mineralextracting industries drilling. Bsi british standards presentation of eu medical devices directive m5 amendment 93 42 eec regulatory updates. Experience with directive 9342 eec combinations of medical devices solution mdd annex i, clause 9. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint.

Council directive 9342eec of 14 june 1993 concerning medical devices. Please find the latest consolidated ivdd 9879ec below. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Experience with directive 9342 eec peter gebhardt 20120905. B council directive 9343eec of 14 june 1993 on the.

Directive 200070ec of the european parliament and of the council of 16 november 2000. If youre a hotwater boiler manufacturer or distributor you need to ensure products meet the essential requirements of the directive before the ce marking is applied. Medizinprodukterichtlinie 9342ewg medical device directive mdd. It applies without prejudice to more specific community food hygiene regulations. Medical devices directive 93 42 eec try it for free on. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs. It is to be noted that to be qualified as an ivd medical device, stand alone software must first fulfil the definition of a medical device. Delivered inhouse, this 1day practical workshop provides an awareness of the european directive 9342eec concerning medical devices. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Bsi training european medical devices directive requirements. Medical devices directive 93 42 eec cardiovascular implants endovascular devices part 1.

Use the following index to navigate into the different sections of the directive. Objectivethis directive lays down the minimum requirements for improving the safety and health protection of workers in the mineralextracting industries through drilling i. 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. Seminar regulatory update on medical devices in asia and eu. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules. Council directive 9343eec on the hygiene of foodstuffs. Application of the classification rules shall be governed by the intended purpose of the devices. Personnel responsible for quality systems for medical device manufacturers will benefit from this. Ce certified and manufactured in accordance with the eec directive 9342, eec 90385 and uni en iso 485. Information forwarded pursuant to article 6 of this directive, in whatever form, is covered by professional secrecy.

Directive 9342eec mdd medical devices directive with. Official journal no page date m1 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. The primary purpose of the directive is to develop a single market in explosives through the harmonisation of product safety standards. The original directive 9342eec published in 1993 was amended in late 2007 with the publication of directive 200747ec, but a combined version of those two directives was not published at that time, making it difficult to interpret the changes directive 200747ec had on the original mdd. 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. Council directive 9316eec of 5 april 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications official journal l 165, 07071993 p. Council directive 9312eec of 23 march 1993 relating to the sulphur content of certain liquid fuels the council of the european communities, having regard to the treaty establishing the european economic community and in particular article 100 thereof. Being a german medical devices company, we set high quality standards safety for the patient, benefits for the user. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. Medical device directive mdd, oder directive 9342eec. Eu medical devices directive m5 amendment 93 42 eec. The european medical devices directive mdd, directive 9342eec requires manufacturers.

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. Again this is not a complete list so be sure to download mdcg 20203. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. This article shall apply without prejudice to council decision 8945eec of 21 december 1988 on dangers arising from the use of consumer products 6 and council directive 9259eec on general product safety 7. B council directive 9342eec of 14 june 1993 concerning. Directive 98 37 ec was subject to a minor amendment by directive 98 79 ec relating to the exclusion of medical devices. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. Download council directive 9342eec on medical devices mdd. Product certification according to certifications schemes like 9342eec medical devices, 9879ec in vitro diagnostic devices medical devices and others. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Nol 1692 official journalofthe europeancommunities. Presented at the hktdc hong kong international medical devices and supplies fair 2009.

Medical device directive mdr deutsch englisch vergleich. If the device is intended for use in combination with other devices or equipment, the. Where a given product does not fall under the definition of medical device, or is excluded by the scope of the directives, other. Bsis european medical devices directive requirements course is designed to provide a top level overview of the guidelines of the european medical device directives mdd 9342eec and comprehensive information on the mdd 200747 changes.