Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. The regulation article 12 of european directive 93 42 eec has made special provision for systems and procedure packs intended for assembly with a view to constituting a device. Turning this feature on will show extra navigation options to go to these specific points in time. The authors of this article isare permitted to use this pdf file to generate. The directive 93 68 eec details the specific changes to each individual directive in articles 2 to. New european regulation for medical devices to replace 9342. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. B council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs oj l 175, 19. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. The regulation article 12 of european directive 9342eec has made special provision for systems and procedure packs intended for assembly with a view to constituting a device. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. New european regulation for medical devices to replace 93. Council decision 93465eec of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives.
Council directive 9385eec of 4 october 1993 on the control. Commission directive 200312ec of 3 february 2003 on the reclassification of breast implants in the framework of directive 9342eec concerning. Questions relating to the implementation of directive 200747 ec 1. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Mdd 93 42 eec article 9 medical device classification 1. B council directive 9343eec of 14 june 1993 on the hygiene. Directive 89336 eec,2 amended by directives 91263eec3, 9231eec4, 93 68eec5 and 93 97eec6 concerning electromagnetic compatibility, with a view to compiling a guide for use in conjunction with the directive. The following provision shall be adopted in accordance with the procedure laid down in article 16a of directive 7793eec.
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. 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. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Commission directive 200312ec of 3 february 2003 on the reclassification of breast implants in the framework of directive 93 42 eec concerning. Ec declaration of conformity directive 7323eec, 9368eec document code 00109155. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs. Devices shall be divided into classes i, iia, iib and iii. The provisions of directive 89391 eec are fully applicable to the matters referred.
Council directive 76768eec on the approximation of the laws of the member states relating to cosmetic products. 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. Qualified person 9102014 d in the case of investigational devices, that the statement referred to in point 4. Ec declaration of conformity directive 7323eec, 9368eec. See how this legislation has or could change over time. Council directive 93104ec of 23 november 1993 concerning certain aspects of the organization of working time official journal l 307, 121993 p.
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. B council directive 9342eec of 14 june 1993 concerning. Council decision 93465eec of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonisation directives. Commission decision 93 465 eec concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives. Council directive 89106 eec council directive 89106 eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products 89106 eec oj l 40, 11. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Commission directive 200312ec on the reclassification of. Contents of technical documentation for mdd 9342eec and. It is very common when searching for guidance on ce marking to come across the ce marking directive 93 68 eec and it often causes confusion, as its purpose is not overly clear.
European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Council directive 76768 eec on the approximation of the laws of the member states relating to cosmetic products. Directive 89336eec,2 amended by directives 91263eec3, 9231eec4, 9368eec5 and 9397eec6 concerning electromagnetic compatibility, with a view to compiling a guide for use in conjunction with the directive. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Council directive 9385eec of 4 october 1993 on the. So 9342eec has been amended 5 times, by 9879ec, 200070ec, 2001104ec, 200332ec, and 200747ec. The qualified person qp shall suffer no disadvantage within the manufacturers organization. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12.
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 ce marking directive 9368eec ce marking association. Directive 200857ec of the european parliament and of the council of 17 june 2008 on the interoperability of the rail system within the community recast text with eea relevance. The provisions of directive 89391eec are fully applicable to the matters referred to in paragraph 2, without prejudice to more stringent andor specific provisions contained in. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. Luckily, there is a consolidated reprint of the medical device directive, issued in 2007, that consolidates the original text with these 5 amendments. Directive 200857ec of the european parliament and of the council show full title. On the one hand, however, the scope is extended to some products currently not covered by the aimddmdd. Medical devices directive 93 42ec evaluation and testing manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. Essentially it was introduced to amend existing directives for them to include the requirement to affix the ce mark. It applies without prejudice to more specific community food hygiene regulations. The procedures for conformity assessment which are.
F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. The directive 9368eec details the specific changes to each individual directive in articles 2 to. In such cases, the person responsible for placing it on the market produces an assembly of several medical devices and if applicable, affix the ce mark to the system. Mdd 9342eec article 9 medical device classification 1. Council directive 9338eec of 14 june 1993 coordinating the. The working group of notified bodies has issued recommendations for the structure of the technical file in the guidance nbmed2. This item of legislation is only available to download and view as pdf. 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. The changes outline requirements of the ce mark, to be attached to a product in order to illustrate a presumption of conformity to the relevant directives. Medical devices directive 9342ec evaluation and testing manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. For further information see frequently asked questions. Commission directive 200312ec on the reclassification. Council directive 89106eec council directive 89106eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products 89106eec oj l 40, 11. Council directive 9338eec of 14 june 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors the council of the european communities, having regard to the treaty establishing the european economic community, and in particular the last sentence of articles 57 2, 66.
B council directive 9343eec of 14 june 1993 on the. 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 implantable medicinal devices, 90396 eec. Council decision of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives. Compliance of medical devices with the new requirements according to article 2 of directive 9342eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if. Frequency converter acs 607 series with power range from 630 kw to 3000 kw and type marking acx 607627. Council directive 9338eec of 14 june 1993 coordinating. In view of the breadth of the scope of the directive and the variety of products covered, it. Council directive 9343eec on the hygiene of foodstuffs. Council decision 93 465 eec of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our sole responsibility that the product. Council decision of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives official journal l 220, 30081993 p.
Council directive 93eec of 5 april 1993 on unfair terms. Council directive 9368eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction products, 89336eec electromagnetic compatibility, 89392eec machinery, 89686eec personal protective equipment, 90384eec nonautomatic weighing instruments, 90385eec active implantable medicinal devices, 90396eec. The revision of the medical devices directive 9342eec. Indicates the geographical area that this provision applies to. Classification shall be carried out in accordance with annex ix. Accreditation is defined in regulation ec 7652008 as an attestation by a national. B council directive 93 43 eec of 14 june 1993 on the hygiene of foodstuffs oj l 175, 19. Council directive 9368eec of 22 july 1993 oj l 220, 30. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Frequency converter acs 607 series with power range. F2 labs can perform the emc and safety testing that is required by the medical device directive for. 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.
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