Classification criteria definitions for the classification. Right click on the link below to download to your computer select save target as. Directive 200070ec of the european parliament and of the council of 16 november 2000. The medical device directive council directive 93 42 eec 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. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 93 42 eec and the active implantable medical devices directive aimdd 90385 eec.
June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. 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. If the device is intended to be used in combination with another device, the. The medical devices directive 9342eec mdd gives manufacturers the opportunity to develop their own compliance program. Whereas, for the purpose of this directive, a harmonized standard is a technical specification european standard or harmonization document adopted, on a mandate from the commission, by either or both of these bodies in accordance with council directive 83189 eec of 28 march 1983 laying down a procedure for the provision of information in the. Normally intended for continuous use for more than 30 days. Council directive 9342eec medical device regulation. 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. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status.
Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status. Read online list of bodies notified under directive. Direttiva 93 42 cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Council directive 90385eec, council directive 9342eec, this regulation.
Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. Council directive 9342eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385eec and 9342eec with respect to. On 5 april 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. The social cost of the large number of accidents caused by the use of machinery can be reduced by. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Overview a medical device is defined in directive 93 42 eec as. Council directive 93 42 eec on medical devices mdd 1993 council directive 9879ec on in vitro diagnostic medical devices ivdmd 1998 new regulations on medical devices. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Because of the many types of devices covered by the mdd, the specific requirements depend on the.
We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs. Eu medical device directive 9342eec labelling requirements. As you are probably aware, eu directive 200747ec modifies the medical devices and active. By way of derogation from directives 90385eec and 9342eec, devices which comply with this regulation may be placed on the market prior to 26 may 2020. This free of charge application was designed to help manufacturers, consultants, notified. The revision of the medical devices directive 9342eec. 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. 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. The medical device directive is intended to harmonise the laws relating to medical devices. 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. Directive 9342eec can be downloaded from the following link. Direttiva 9342cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici.
By way of derogation from directives 90385eec and 9342eec, conformity assessment bodies which comply with this regulation may be designated and notified prior 26 may 2020. Commission communication in the framework of the implementation of the council directive 93 42eec concerning medical devices. These sections are reproduced below for your information or. Commission communication in the framework of the implementation of the council directive 93 42eec concer ning medical devices. B council directive 9342eec of 14 june 1993 concerning. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. The essential requirements of the medical device directive 9342eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. The content of this page deals only with the medical devices directive 93 42 eec. By way of derogation from directives 90385 eec and 93 42 eec, devices which comply with this regulation may be placed on the market prior to 26 may 2020. The whole directive you have selected contains over 200 provisions and might take some time to download.
The medical device directive,published by the european commission from the european regulatory. Since the 14th june of 1998 each medical device must carry a ce mark. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 9342eec and the active implantable medical devices directive aimdd 90385eec. All books are in clear copy here, and all files are secure so dont worry about it. Guide to medical device directive compliance 9342eec. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the medical device. This site is like a library, you could find million book here by using search box in the header. They entered into force on 25 may 2017 and will progressively. Council directive 9342eec of 14 june 1993 concerning. It applies without prejudice to more specific community food hygiene regulations. Commission communication in the framework of the implementation of council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices.
Nonautomatic weighing instruments directive 201431eu. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. The medical devices directive 93 42 eec mdd gives manufacturers the opportunity to develop their own compliance program. 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. Nol 1692 official journalofthe europeancommunities. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules.
Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Medical devices directive 9342eec pdf download 10yi83. Or download the pdf of the directive or of the official journal for free this website uses cookies to ensure you get the best experience on our website. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Directive 9879ec of the european parliament and of the council of. The first edition of this standard was drafted in a period when the active implantable medical device directive aimdd90385eec and the medical device directive mdd9342eec were relatively new and the in vitro diagnostic medical. Posts tagged council directive 9342eec massimop z annex 17 xvii correlation table annex, annex xvii, article, correlation table, council directive 90385eec, council directive 9342eec, mdr. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. The essential requirements of the medical device directive 93 42 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. This document is available in either paper or pdf format. Information supplied by the manufacturer of medical devices format.
If the appliance is at the same time a medical device within the meaning of directive 9342eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this directive. Understanding the machinery directive 2006 42ec the directive has been put in place because. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Please find the latest consolidated mdd9342 eec below, with the biggest change in 2007 which came into. 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. Application of the classification rules shall be governed by the intended purpose of the devices. Medical devices directive 93 42 eec pdf download 10yi83. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of biocidal. Download council directive 9342eec on medical devices mdd.
Posts tagged council directive 93 42 eec massimop z annex 17 xvii correlation table annex, annex xvii, article, correlation table, council directive 90385 eec, council directive 93 42 eec, mdr. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be. Directive 93 42 eec can be downloaded from the following link. 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. Download b council directive 9342eec of 14 june 1993 concerning. Medical devices directive 93 42 eec try it for free on. Dexdor dosing calculator allows healthcare professionals to calculate easily the infusion rate of dexdor. Medical devices directive 9342eec try it for free on. Directive 200747ec guidance document for mdd 9342eec.
What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Medical devices directive 93 42 eec cardiovascular implants endovascular devices part 1. Read online b council directive 9342eec of 14 june 1993 concerning. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs. Council directive 93 42 eec of 14 june 1993 concerning medical devices. 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. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Noise emission outdoor equipment directive 200014ec.
Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Commission communication in the framework of the implementation of the council directive 93 42 eec concerning medical devices. Download declaration in word or pdf format, with your logo. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 93 43 eec on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. Commission communication in the framework of the implementation of the council directive 93 42 eec concer ning medical devices publication of titles and references of har monised standards under union har monisation legislation text with eea relevance 2017c 38903 eso 1 reference and title of the standard. Medical devices internal market, industry, entrepreneurship. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. By way of derogation from directives 90385 eec and 93 42 eec, conformity assessment bodies which comply with this regulation may be designated and notified prior 26 may 2020. Dexdor dosing calculator for ios free download and software. Regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec text with eea relevance. Dexdor dosing calculator for ios free download and. Notified body aka, independent assessment required. Council directive 9342eec of 14 june 1993 concerning medical devices. 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.
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