Directive 9344eec amending directive 89392eec machinery. The ce marking is only required if a product is covered by one or more ce marking directives or regulations. The original directive has since been repealed by directive 200695ec which effectively consolidated the original directive 7323eec with the ce marking directive 9368eec. Ce marking and european medical device directive 9342cee. Ce marking figure1 is a declaration by the manufacturer. What are the ce marking regulations and directives.
B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. These regulations contain the legislative measures necessary for the implementation of three european community directives. This free of charge application was designed to help manufacturers, consultants, notified. Only safe, flawless, and quality goods should be available on the european market at least, thats the objective of the ce mark. Active implantable medical devices directive 90385eec. To enable your organization to achieve ce marking certification sgs is notified body 0120 under directive 9342eec for all devices including drug device combinations and associated directives 200332ec animal tissue, 200550ec total joint implants and 200747ec amendments. B council directive of 19february 1973 on the harmonization of the laws of member states relating to electrical equipment designed for use within certain voltage limits 7323 eec oj l 77, 26. In 1993 that directive was amended by directive 9368eec5, the socalled ce marking directive, solely in respect of the procedures for conformity. The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. Council directive 9368eec of 22 july 1993 oj l 220 of 30 august 1993 council directive 9342eec. There are changes that havent been incorporated into the text of this council directive 93 68 eec. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards.
Or download the pdf of the directive or of the official journal for free. 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. He worked in the medical industry in sales and management positions for over 10 years prior to joining bsi inc. Directive 9368eec amending directives 89392eec machinery atex directives. In 1993 that directive was amended by directive 9368eec, the socalled ce. The primary aim of ce marking is to facilitate free trade of products within the eu by. The directive amends 11 council directives adopted under the new approach to technical harmonization and standards and the low voltage directive 7323eec under the old approach to remove inconsistencies between them in the provisions for ce marking and to provide common rules for such provisions in future directives. The ivd directive was amended and corrected over time. European commission dg entri4 2 toys only essential safety requirements defined in the directive detailed technical specifications in.
Communication of the commission within the framework of council directive 7323eec of 19 february 1973 on the harmonisation of the laws of the member states relating to electrical equipment designed for use within certain voltage limits, as amended by council directive 9368eec official journal c 202 of. 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. Please find the latest consolidated ivdd 9879ec below. 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. Low voltage directive 7323eec amended 9368eec simple pressure vessels 87404eec amended 90488.
Ce marking symbolizes that a product is covered by a harmonised eu directive or regulation. As of 2019, ce marking was not required by countries of the central european free trade. Official journal no page date m1 council directive 93 68 eec of 22 july 1993 l220 1 30. Ppe guidelines guide to application of the ppe directive. Essentially it was introduced to amend existing directives for them to include the requirement to affix the ce mark. Council directive 9344eec of 14 june 1993 amending directive 89392eec on the approximation of the laws of the member states relating to machinerythe 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. In 1993 that directive was amended by directive 93 68 eec, the socalled ce marking directive, solely in respect of the procedures for conformity assessment and conformity marking. Active implantable medical devices internal market. Finally, the readers attention is drawn to the fact that all references to the ce marking and ec declaration of conformity relate only to the emc directive and that the freedom to place an apparatus on the market in the eu internal market is. According to 9368eec ce marking for every cemarked product the supplier shall have a declaration. The requirements for ce marking are set out in directives and. States relating to personal protective equipment as amended by directive 9368eec, directive. Ce marking has been introduced by the council directive 9368eec of 22.
You can download the complete directive in pdf by cliquing. Directive as last amended by directive 93 68 eec oj l 220, 30. Council directive 93 68 eec of 22 july 1993 oj l 220, 30. European union directives the eu is one of the largest publishers of online information in the world and the hunt for information can seem complex. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Please find below a list of the ce marking directives and regulations european union directivesregulations that require the affixing of a ce mark to the products covers by them.
It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec and it often causes confusion, as its purpose is not overly clear. Council directive 9342eec concerning medical devices, as amended. Within the professional audiovideo industry, standards of. Instead, they are listed below for reference and previous revised dated versions are available on more resources. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. The ce marking directive amended both of these directives. Council directive 9368eec of 22 july 1993 amending. Decision of 14 july 1993 not yet published in the official.
Non automatic weighing instruments nawias, weighing instruments that require the action of gravity to determine the mass and require the intervention of an operator during weighing, which are first placed on the eu market and put into use in eu member states must comply with the nonautomatic weighing instrument directive 90. The european union eu directives are binding legislation addressed to its member states. Ce marking is a certification mark that indicates conformity with health, safety, and. Ce marking ce mark, eu council directive 89106eec of. The term ec mark appeared in this directive is out of date and has been officially replaced by term ce marking in. Directive 9368eec ce marking directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec 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. Ce marking and european medical device directive 93 42cee. The objective of this amendment was to align the provisions concerning conformity assessment and the ce marking of. Quinn is the west coast business development manager and bsi notified body representative for bsi, inc. The ce marking of products is intended to support the free movement of goods within the european economic area. Ce conformity marking, which are intended to be used in the technical harmonization directives8.
Communication of the commission within the framework of council directive 7323 eec of 19 february 1973 on the harmonisation of the laws of the member states relating to electrical equipment designed for use within certain voltage limits, as amended by council directive 93 68 eec official journal c 202 of 27. The original directive has since been repealed by directive 200695ec which effectively consolidated the original directive 7323 eec with the ce marking directive 93 68 eec. Ce marking assistant, your declarations of conformity online. M1 council directive 9368eec of 22 july 1993 l220 1 30. The amendments introduced by directive 93 42 eec are indicated in bold, the amendments following directive 93 68 eec are in italic. All references to the ce marking and ec declaration of conformity in this. Celab can accomplish all the required tests in order to affix the ce marking related to emc, lvd, red, mdd. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. Please find below a list of the ce marking directives and regulations european union directives regulations that require the affixing of a ce mark to the products covers by them. Council directive 9368eec of 22 july 1993 oj l 220, 30. Ec regulation and ce marking a brief guide canford audio. In 1993 that directive was amended by directive 9368eec5, the socalled ce marking directive, solely in respect of the procedures for conformity assessment and conformity marking. The objective of this amendment was to align the provisions concerning conformity assessment and the ce marking of electrical equipment on those introduced for the.
Ce marking internal market, industry, entrepreneurship. Within the professional audiovideo industry, standards of electrical safety have always been high. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec. To enable your organization to achieve ce marking certification sgs is notified body 0120 under directive 93 42 eec for all devices including drug device combinations and associated directives 200332ec animal tissue, 200550ec total joint implants and 200747ec amendments. Role of ce marking in the placing on the market of. The mark proves that the product in question conforms to eu health and safety standards, whether its toys or construction machines. The eu declaration of conformity web application helps the manufacturers, the importers, consultants and the notified bodies to keep under control the eu declaration of conformity related to ce marking. Council directive 9342eec of 14 june 1993 concerning medical devices. Delivery of an instruction manual in the language of the user, which sets out. Directive 90384eec nonautomatic weighing instruments. 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. The european free trade association efta countries, with the exception of switzerland.
All products that bear ce marking must comply with all provisions of the applicable directives. Ce marking on a product is a manufacturers declaration that the. This directive including the mutual recognition of their 10. The ce marking is also found on products sold outside the eea that are manufactured in, or designed to be sold in, the eea.
Toys directive 88378eec of 3 may 1988 as amended by 9368eec of 22 july 1993. Council directive 9344eec of 14 june 1993 amending directive 89392eec on the approximation of the laws of the member states relating to machinerythe 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. Ce marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the european economic area eea. These guidelines are intended to be a manual for all parties directly. The european free trade association efta countries comprise. This ce marking directive has been drawn up to allow apparatus to move freely throughout the eu and to guarantee a satisfactory electromagnetic environment.
Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission. Environmental design for energyrelated products directive 2009125ec. B council directive 9342eec of 14 june 1993 concerning. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Eec council directive 9368eec of 22 july 1993 ce logo. Every day a huge range of information goes online, including legislation, statistics, press releases, policy reports and more. All references to the ce marking and ec declaration of conformity in this guide. 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. Council directive 89106eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products this directive has been amended by the following council directives. Directive 2008 68 ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. The pressure equipment directive ensures stationary pressure equipment can be circulated within the eu and be safe at the same time. 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 ce marking directive 9368eec ce marking association.
Medical devices directive 9342eec your guide to ce marking. This makes the ce marking recognizable worldwide even to people who are not familiar with. Ce marking ce mark for appliances burning gaseous fuels. This makes the ce marking recognizable worldwide even to.
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