Council directive 9316eec of 5 april 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications the council of the european communities, having regard to the treaty establishing the european economic community, and in. Directive 89336 eec,2 amended by directives 91263eec3, 9231eec4, 93 68 eec5 and 93 97eec6 concerning electromagnetic compatibility, with a view to compiling a guide for use in conjunction with the directive. 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, in cooperation with the european parliament 2. Council directive 93 68 eec of 22 july 1993 oj l 220, 30. This directive reflects the eu s concern for a need to establish common minimum standards for the protection of animals at the time of slaughter or killing in order to ensure rational development of production and to facilitate the completion of the internal market in animals and animal products. Throughout the text the term ec mark was replaced by ce marking. Other directives and regulations prescribing harmonized european standards. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Therefore i am attaching the pdfs to this posting for anyone who is. L 37418 en official journal of the european union 27. Eu medical device directive 93 42 eec labelling requirements sterile barrier association, pennygate house, st weonards, herefordshire, hr2 8pt, uk tel 01981 580 190 mailto. The directive ceased to be in force on 31 may 2015 and was repealed by regulation ec no 12722008 of the european parliament and of the council of 16 december 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67548 eec and 199945ec, and amending regulation ec no 19072006 text. Council directive 9368eec of 22 july 1993 amending directives 87404eec.
Council directive 93 42 eec of 14 june 1993 concerning medical devices. They supersede guidance on the application of that directive which was given in the commissions communication of 15 december 19812 and the guidelines on the application of council directive 7323eec of july 1997. In 1993 that directive was amended by directive 93 68 eec5, the socalled ce marking directive, solely in respect of the procedures for conformity. There have been difficulties in establishing exactly what equipment comes within the scope of the directive, and in october 1993 the commission published guidelines on the application of the council directive 89336 eec. To ensure european harmonization action is required at community rather than member state level. 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. Our policy towards the use of cookies techstreet, a clarivate analytics brand, uses cookies to improve your online experience. An example for the declaration of incorporation is given in annex b. The directive applies to equipment with an rf broadcasting or receiving function. Ce marking and european medical device directive 9342cee.
Directive 9258eec safety andor health signs safety and. Di rective as last amended by directive 93 68 eec oj no l 220, 30. Council directive 9398eec of 29 october 1993 harmonising the term of protection of and certain related rights is a european union directive in the field of eu law, made under the internal market provisions of the treaty of rome. 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. Medical devices internal market, industry, entrepreneurship. According to the directive 93 68 eec in the future the cemarking.
The electromagnetic compatibility emc directive 2004108ec repeals the previous emc directive 89336eec3 as amended by directives 91263eec4, 9231eec5, 93 68 eec6 and 93 97eec7 and maintains the same objectives to. Pressure equipment directive eu offshore authorities group. Medical devices directive 93 42 eec try it for free on. Directive as last amended by the 1994 act of accession. Regulation eu 2017745 of the european parliament and of. The ce marking directive 93 68 eec was adopted on july 22, 1993 in order to introduce a harmonized set of rules concerning the affixing and use of ce marking. With notified body status for many of the european directives, bsi can offer one of the most comprehensive ce marking ce mark certification services in the world and has a team of experts who understand precisely what each directive requires for. Please find the latest consolidated ivdd 9879ec below.
The clause in the new directive article 14b indicates that. Safety signs, health signs, prohibition sign, warning. 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. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec. 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.
Regulation ec no 18822003 of the european parliament and of the. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. New european regulation for medical devices to replace 93. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. July 1993 came into force in all territories of the european union eu on 1. B council directive 9265eec of july 1992 laying down.
The ce mark on the product will offer a presumption of conformity with the relevant directives. Eu directive 76769eec, am ended by commission decis ion 2006122ec, relating to restrictions on the marketing and use of perfluorooctane sulfonates pfos opto 22 products the pfos commission decision restricts the intentional use of pfos substances as constituents in certain preparations, products and articles placed on the eu market above. I have created a new pdf version from the eu mdd 93 42 eec for use on mobile devices. Directive 9368eec of 22 july 1993 l 220 of 30 august 1993. Ce marking is a part of the eu s harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. 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.
Instead, they are listed below for reference and previous revised dated versions are available on more resources. Active implantable medical devices directive 90385eec cableway installations directive 20009ec construction products. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Decision of 14 july 1993 not yet published in the official. 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. 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. Directive 93 68 eec amending directives 89392 eec machinery atex directives. This amended directive 7323 eec which was subsequently replaced by directive 200695ec. Council directive 7323eec of 19 february 1973 on the harmonization of the laws of member states relating to electrical equipment designed for use within certain voltage limits. Any product or material designed or clearly intended for use in play by.
Ce marking directive 9368eec your consultant on eu. It complements the dangerous substances directive 67548 eec and replaces a previous dangerous preparations directive 88379 eec. The ce marking directive 9368eec ce marking association. Which products are covered by the radio equipment directive 201453 eu. This item of legislation is only available as the original as adopted by eu version in pdf. Detailed technical specifications in european standards new approach directive. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. Eu farming council directive 93119ec on the protection. 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.
L 358100 en official journal of the european communities 31. Field of application definitions requirements technical specifications free. Compliance of medical devices with the new requirements according to article 2 of directive 93 42 eec, member states shall take all necessary steps to ensure that devices. However, there are some known subsequent changes to council directive 9368eec. Ce marking and european medical device directive 93 42cee. Registered in england under the industrial friends and provident society no. The medical device regulation mdr 2017745 will replace the eu s current medical device directive 93 42 eec and the eu s directive on active implantable medical devices 90385 eec. Directive 93 eec, directive 986ec of the european parliament and of the council, directive 200529ec of t he european parliament and of the council and directive 201183 eu of teh european parliament and of the council as regards better enforcement and modernisation of eu. Council directive 98 93 ec of 14 december 1998 amending directive 68 414 eec imposing an obligation on member states of the eec to maintain minimum stocks of crude oil andor petroleum products. This has been addressed by issuing a corrigendum7 to directive 93 68 eec, aligning all language versions. Personal protective equipment ppe are products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities. Ce marking internal market, industry, entrepreneurship and.
Manual of decisions for implementation of the sixth and seventh amendments to directive 67548 eec on dangerous substances directives 79831 eec and 9232 eec european commission joint research centre eur 20519 en institute for health and consumer protection european chemicals bureau 2002. You can download the complete directive in pdf by cliquing on the following link. Statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Readers attention is drawn to the fact that this guide is intended only to facilitate the application of directive 200948ec and it is the relevant national transposition of the text of the directive which is legally binding. 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. Council directive 91439 eec of 29 july 1991 on driving licences official journal l 237, 24081991 p. Council directive 9242 eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels 17. The directive does not go beyond what is required to achieve the objective. The council of the european union, having regard to the treaty establishing the european community, and in particular article 43 thereof, having regard to the proposal from the commission 1, having regard to the opinion of the european.
Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission, in cooperation withthe2 european parliament, having regard tothe opinion oftheeconomic andsocial committee3, whereas the council has already adopteda series of. With notified body status for many of the european directives, bsi can offer one of the most comprehensive ce marking ce mark certification services in the world and has a team of experts who understand precisely what each directive requires for each product to make your life easier. Council directive 9893ec of 14 december 1998 amending. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission, in cooperation withthe2 european parliament, having regard tothe opinion oftheeconomic andsocial. B council directive 9342eec of 14 june 1993 concerning. The ivd directive was amended and corrected over time. Council directive 7323 eec of 19 february 1973 on the harmonization of the laws of the member states relating to electrical equipment designed for use within certain voltage limits 18. Questions relating to the implementation of directive 200747 ec 1.
I have had benefit from reading several threads, downloading attachments in the elsmar forums. Directive 9368eec amending directives 89392eec machinery atex directives. Objectivethis directive aims at the free market circulation on machinery and at the protection of workers and consumers using such machinery. Eec council directive 9368eec of 22 july 1993 ce logo. You can download the complete directive in pdf by cliquing. 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.
The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. Comprehensive guidance on the implementation of eu product rules can be. Council directive 9693ec of 17 december 1996 on the. Directive 9368ec introduced the harmonized provisions related to ce marking. The ce marking is only required if a product is covered by one or more ce marking directives or regulations. Lvd guidelines on the application of the low voltage.
Ce marking ce mark, electromagnetic compatibility emc. View changes to legislation for this legislation item. 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. 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 stable derivates of. The european court of justice had ruled in 1985 that dangerous substances directive 67548 eec.
Directive 2006116ec of the european parliament and of the council of 12 december 2006 on the term of protection of and certain related rights codified version is the consolidated version of 93 98ec with amendments that is in force since 2007. Europa guidelines on the application of directive 200695ec. For pumps without driver this declaration of incorporation should be used. This directive including the mutual recognition of. European commission dg entri4 3 toys scope definition article 1. May 1989, as amended by directive 9231eec dated 28. This directive including the mutual recognition of their. You may need either an euec european authorized representative based in eu27 countries or a.
Council directive 9368eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction. Ce marking internal market, industry, entrepreneurship. There are changes that havent been incorporated into the text of this council directive 93 68 eec. Directive 9344eec amending directive 89392eec machinery. In view of the breadth of the scope of the directive and the variety of products covered, it. Last amended by directive 91496 eec oj no l 268, 24. It defines essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. Council directive 9693ec of 17 december 1996 on the certification of animals and animal products.
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