Conformity with medical device directive 93 42 eec is mandatory all devices. Council directive 93 42 eec 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 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Directive 90385 eec and directive 93 42 eec should be adopted in accordance with council decision 1999468ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission 1. Directive 93 68 eec ce marking 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. Commission directive 200312ec on the reclassification of. 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. Medical devices directive 93 42 eec, as amended medical devices regulation eu 2017745 comments the content of the eu declaration of conformity are speci. The table is an excerpt from the mdrivdr smart support available in compliance navigator. Directive 93 42 eec and the medical devices regulation eu 2017745 eamonn hoxey. Overview a medical device is defined in directive 93 42 eec as.
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. The medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. Amendment to the medical devices directive 93 42 ec and 90385 eec. Directive 93 42 eec harmonized european standards, available for a fee. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Medical devices directive 9342eec mdd and subsequent amendments. Medical device directive mdd 93 42 eec as amended by 200742ec pavan kumar malwade 01 april 2016 1. Amendment to the medical devices directive 93 42 ec and 90385 eec published on. This document is meant purely as a documentation tool and. Commission communication in the framework of the implementation of the council directive 93 42 eec of 14 june 1993 concer ning medical devices publication of titles and references of har monised standards under union har monisation legislation text with eea relevance 2015c 22602. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination. Commission directive 200312ec on the reclassification. Council directive 93 42 eec of 14 june 1993 concerning medical devices document generated.
Medical devices guidance document classification of. Medical devices directive testing mdd 9342eecf2 labs. Manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. A slight difference exists between the definition in article 12 a of directive 93 42 eec and in article 12 of directive 90385 eec. Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic andor therapeutic purposes and necessary. Download council directive 9342eec on medical devices mdd. Directive 200070ec of the european parliament and of the council of 16 november 2000. On 21 september 2007, the european commission published an amendment to the medical device directives 90 42 eec and 90385 eec. 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. Guidance on medical devices, active implantable medical. Ec declaration of conformity according to mdd 9342eec gima. F2 substituted by 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. Mdd annex ix classification criteria medical device. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a.
The medical devices directive 93 42 eec link to support material guides particularly useful to manufacturers are the meddev guidance documents which promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Unofficial copy if printed see intranet for latest released version for internal use only. European medical device directive essential requirements. Medinfo council directive international expert information. Directive 9342eec as set out in annex ii section 3. Mdd annex ix classification criteria definitions definitions for the classification rules. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. While the mdd comprises 23 articles and 12 annexes over 60 pages.
Directive 93 42 eec relating to medical devices, published in oj 98c 24205. We herewith declare that the products listed above are in compliance with the requirements set out in the. Essential requirements annex i, 93 42eec as amended by directive 200747ec. Comparison of the articles of the european medical devices. Council directive 9368eec of 22 july 1993 amending. These guidelines should be read in conjunction with the directive 90385 eec relating to active implantable medical devices and the directive 93 42 eec relating to medical devices. If the appliance is at the same time a medical device within the meaning of directive 93 42 eec 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. Commission directive 200312ec of 3 february 2003 on the reclassification of breast implants in the framework of directive 93 42 eec concerning.
The manufacturer should first decide if the product concerned is a medical device as defined in directive 93 42 eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. The ce marking directive 9368eec ce marking association. Eu directives are being published on this site to aid cross referencing from uk. Medical devices directive 9342eec pdf download 1obpox.
F2 labs can perform the emc and safety testing that is required by the medical device directive. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of biocidal products on the market text with eea relevance article 2 directive 93 42 eec is hereby amended as follows. They provide a practical support for the uniform application of these directives. Council directive 9342eec of 14 june 1993 concerning medical devices. Council directive 9342eec of 14 june 1993 concerning.
Medical devices directive 93 42 eec, as amended medical devices regulation eu 2017745 comments for each device, the manufacturer has to plan, establish, document, implement, maintain and update a postmarket surveillance pms system that is proportionate to the risk class and appropriate for the type of device. Medical devices directive 93 42 ec evaluation and testing. Medical devices guidance document classification of medical. A medical device is defined in directive 93 42 eec as. Directive medical devices directive 93 42 eec last official journal reference wednesday 25th of march 2020 description. Use of noneu standards is possible only in the absence of an eu standard. Medical devices directive 93 42 ec evaluation and testing manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. Schedule meet the provisions of the council directive 93 42 eec of 14 june 1993 concerning medical devices. Eu directives are being published on this site to aid cross referencing from uk legislation. Medical devices directive 93 42 eec try it for free on. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. The manufacturer of partly completed machinery or his.
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 content of this page deals only with the medical devices directive 93 42 eec. 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. Council directive 93 42 eec 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 90385 eec and 93 42 eec with respect to. Council directive 93 68 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, 90384 eec nonautomatic weighing instruments, 90385 eec active.
Council directive 93 42 eec 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. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om. Directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. Medical devices directive 93 42 eec medical devices utilizing animal tissues and their derivatives part 1. Employ sgs to audit your compliance with the ce marking directive, and benefit from 9342eec certification.
Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in council directive 89686 eec and. Council directive on the harmonization of the laws of. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. This represents the minimum standard a manufacturer is expected to. M1 council directive 93 42 eec of 14 june 1993 l 169 1 12. Council directive 93 42 eec of 14 june 1993 concerning medical devices. B council directive 9342eec of 14 june 1993 concerning. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Medical device means any instrument, apparatus, appliance, software. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. Active implantable medical devices internal market. Conformity assessment conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of directive 93 42 eec. Protective garments that were identified as medical devices, now became ppe as well.
This approval is valid until the piry date provided that the manufacturer fulfils the obligations imposed by. Declaration of conformity the conformity assessment annexes of the mdd indicate that the manufacturer has to draw up a written declaration of conformity. Having regard tothe treatyestablishing the european economic. Council directive 9342eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. Article 1 of the medical devices directive 93 42 eec nrlcontaining medical devices i. Europa enterprise guidelines on the implications of the. 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. The new directive 200747ec introduces substantial changes to the previous text.
The other references of standards published in the commission communication 2017c 38903 6 should therefore also be included in this decision. Council directive 93 42 eec on medical devices mdd 1993. Duration transient normally intended for continuous use for less than 60 minutes. This document contains confidential, proprietary information of carefusion or one of its subsidiaries. Directive 2006 42 ec makes provisions for partially completed machinery in a procedure that is outlined in article procedure for partly completed machinery. Comparison of the annexes of the european medical devices. Medical devices directive 93 42 eec mdd and subsequent amendments.
Products within the scope of mdd article 1 of the directive defines a medical device to mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used. Following the latter directive, accessories are by definition medical devices, whilst following directive 93 42 eec, a. 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. Download declaration in word or pdf format, with your logo. F1 inserted by 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. The guidelines deal with specific issues in the context of the aforementioned. 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. Essential requirements annex i, 93 42 eec as amended by directive 200747ec. This form may be used as a list if filled accurately. Mdd the medical devices directive product assurance by dnv gl.
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