Ce marking is the symbol as shown on the top of this page. Ce directives pdf active implantable medical devices directive 90385eec cableway installations directive 20009ec construction products regulation 3052011eu. Directive 2004108ec relating to electromagnetic compatibility and repealing directive 89336 eec oj l 390 of 31 december 2004. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. Ce marking has been introduced by the council directive 9368eec of 22 july 1993. The ppe directive 89686 eec was repealed with effect from april 2018 and the ppe regulation eu 2016425 now applies. The directive amends 11 council directives adopted under the new approach to technical harmonization and standards and the low voltage directive 7323 eec 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.
Ce marking 9368eec directive information available. Directive 93 68 eec amending directives 89392 eec machinery atex directives. Directive 9368eec amending directives 89392eec machinery atex directives. The ce marking is only required if a product is covered by one or more ce marking directives or regulations. The construction products directive 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. Article 2 directive 87404eec is hereby amended as follows. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. Medical devices directive 93 42 eec the medical devices directive mdd applies exclusively to complete endproducts and their readytouse accessories intended to be used for the diagnosis, prevention, monitoring. Council directive 9315eec of 5 april 1993 ce marking. Active implantable medical devices directive 90385eec. 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 only guaranteed when applying all relevant legislation. The marking of terminal equipment complying with this directive shall consist of the ce marking consisting of the initials ce, followed by the identification number of the notified body involved in the production control stage and a symbol indicating that the equipment is intended and is suitable to be connected to the public. Other directives and regulations prescribing harmonized european standards. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec.
Low voltage directive 7323eec council directive of 19 february 1973 on the harmonization. Medical devices directive 9342eec your guide to ce marking. Only safe, flawless, and quality goods should be available on the european market at least, thats the objective of the ce mark. The term ec mark appeared in this directive is out of date and has been officially replaced by term ce marking in 1993 in the ce marking directive 93 68 eec. The pressure equipment directive ensures stationary pressure equipment can be circulated within the eu and be safe at the same time. Ce marking is now used in all eu official documents. If reduction or enlargement of the ce marking is necessary, the proportions given by the above backgroundgrid shall be followed.
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. The term initially used was ec mark and it was officially replaced by ce marking in the directive 9368eec in 1993. Environmental design for energyrelated products directive. Guide to assist the common application of the directive 2004108ec. Directive 7323 eec, low voltage directive for electrical apparatus directive 89336 eec, emc electromagnetic compatibility directive 93 68 eec, ce marking international standard iec 61215 ed. Ce marking entered our lives in 1992, as the new approach mark. Low voltage directive 7323 eec amended 93 68 eec simple pressure vessels 87404 eec amended 90488 eec, 93 68 eec toys 88378 eec amended 93 68 eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Personal protective equipment directive 89686eec bsi. 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. The ce marking directive 93 68 eec was adopted on july 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the affixing and use of ce marking. 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 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 is a certification mark that indicates conformity with health, safety, and.
For this reason there is no requirement for ce marking. Ce marking in order to demonstrate that certain products are legal within europe, it is a requirement of national legislation implementing eu new approach directives to apply ce marking to certain. 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. Ce marking and european medical device directive 9342cee. The ce marking directive 9368eec was adopted on july 22, 1993 in order to introduce a harmonized set of rules concerning the affixing and use of ce marking. Each legislation directive or regulation has a scope, which describes in detail the types. The low voltage directive 200695ec this directive applies to electrical equipment designed for use. Active implantable medical devices directive 90385 eec. Ce marking for military aerospace and defence products. But the requirements for the use of ce logo were inconsistent until 1993. Role of ce marking in the placing on the market of.
Active implantable medical devices directive 90385eec try it for free on. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Ce marking ce mark, eu council directive 89106eec of 21. A transition process has been outlined in article 47 of the regulation which states without prejudice to member states shall not impede the making available on the market of products covered by directive 89686 eec which. The medical device directive 93 42 eec this directive applies to medical devices, their accessories and software. The ce marking directive 9368eec was adopted on july 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the affixing and use of ce marking. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. 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. Directive 9368eec amending directives 89392eec machinery. In june 1993 the commission introduced the directive 93 68 eec. Council directive 9342eec of 14 june 1993 concerning. The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. Council directive 9368eec of 22 july 1993 amending.
Comprehensive guidance on the implementation of eu product rules can be. 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 letters ce are the abbreviation of french phrase conformite europeene which literally means european conformity. The backgroundgrid should be considered only as an aid and is not part of the ce marking. 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. Directive 9368ec introduced the harmonized provisions related to ce marking. Pressure equipment directive ped 2014 68 eu formerly 9723ec of the eu sets out the standards for the design and fabrication of pressure equipment pressure equipment means steam boilers, pressure vessels, piping, safety valves and other components and assemblies subject to pressure loading generally over one litre in volume and having a maximum pressure more than 0. After may 1st 2004 the ce mark will be compulsory for all ppe placed on the market. 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.
This free of charge application was designed to help manufacturers, consultants, notified. Ce marking has been introduced by 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. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof. The european union eu directives are binding legislation addressed to its member states. According to 93 68 eec ce marking for every ce marked product the supplier shall have a declaration of conformity and prepare documentation to prove compliance with applicable standards and directives. The letters ce are the abbreviation of french phrase conformite europeene which literaly means european conformity. Ce mark is also in use, but it is not the official term. Ppe without a ce mark already in use before this date can continue to be used. According to the directive 93 68 eec in the future the ce marking consists of the letters ce with the following face. If reduction or enlargement of the ce marking is necessary, the proportions given by the above backgroundgrid shall be. Ce marking internal market, industry, entrepreneurship and. Ce marking ce mark, eu council directive 89106eec of. In 2017 a new regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices has been published in the official journal of the european union on 5 may 2017, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec.
Eec council directive 9368eec of 22 july 1993 ce logo. Official journal no page date m1 council directive 93 68 eec of 22 july 1993 l220 1 30. The ce marking directive 9368eec ce marking association. The term initially used was ec mark and it was officially replaced by ce marking in the directive 93 68 eec in 1993. Download the most important ce product guidelines here. Ce marking internal market, industry, entrepreneurship. Council directive 7323eec of 19 february 1973 on the harmonization of the laws of the member states relating to electrical equipment designed for use within certain voltage limits12. Please find the latest consolidated ivdd 9879ec below. New approach directives are based on four fundamental principals. The directive 93 68 eec details the specific changes to each individual directive in articles 2 to.
Have a look on the manufacturers nameplate that appears on any instrument sold in the european union and you will see it. The objective of this amendment was to align the provisions concerning conformity assessment and the ce marking of. Directive 2008 68 ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous. This directive has been amended by the following council directives. The mark proves that the product in question conforms to eu health and safety standards, whether its toys or construction machines. Ce marking directives now cover many product areas. Frequently asked questions about ce marking or questions. What are the ce marking regulations and directives. The ivd directive was amended and corrected over time. Legal requirements relate to various categories of goods and must be completely met before the manufacturer can legally affix the ce mark on its machines. You can download the complete directive in pdf by cliquing. The actual ce marking is the letters ce which a masymbol nufacturer affixes to certain products for access to the european market consisting 32 eu countriesof and also referred to as the european economic area or eea. What ce directives are relevant to instrumentation. 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. Ce marking according to the directive 93 68 eec the ce marking consists of the letters ce with the following face. This ce marking directive has been drawn up to allow apparatus to move freely throughout the eu and to guarantee a satisfactory electromagnetic environment. This document is meant purely as documentation tool and the. Role of ce marking in the placing on the market of electronic. Directive 90384eec nonautomatic weighing instruments. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission. 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. For instance, in the directive 200747ec, of 5 september 2007, amending the directives 90385 eec, 93 42 eec.
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. Within the professional audiovideo industry, standards of electrical safety have always been high. This document was prepared by the technical committee tc of epsma to find a common understanding and interpretation of ce marking among. Official journal no page date m1 council directive 93 68 eec of 22 july 1993 l220 1. Council directive 9315eec of 5 april 1993 on the harmonization of the. Medical devices directive 93 42 eec the medical devices directive mdd applies exclusively to complete endproducts and their readytouse accessories intended to. In 1993 that directive was amended by directive 93 68 eec5, the socalled ce marking directive, solely in respect of the procedures for conformity assessment and conformity marking. 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 directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating. 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.
28 515 62 1397 918 1480 1164 1036 580 95 1135 581 693 444 1044 249 1481 1478 1205 617 1028 1167 766 856 1232 287 215 764 526 546 45 1342 15 789 433 397 1349 1042 1402 39 425 1005 462 1101 1467 972 1182