Directive 9368ec introduced the harmonized provisions related to ce marking. Van leeuwen and others published technical guidance document on risk assessment in support of commission directive 93 67 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. You can download the complete directive in pdf by cliquing on the following link.
Council directive 9893ec of 14 december 1998 amending. The abbreviation ce comes from the french phrase conformite europeene which literally translates as european conformity. 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. The directive 9368eec details the specific changes to each individual directive in articles 2 to. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Council directive 93 42eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. Ce marking is a certification mark that indicates conformity with health, safety, and. Low voltage directive, 7323 eec, the emc directive, 89336 eec, including amendments by the ce marking directive, 93 68 eec product type designation. This document is meant purely as documentation tool and. Construction products 89 106eec amended by 9368eec. In 1993 that directive was amended by directive 93 68 eec5, the socalled. Directive 93 42 eec s on medical devices, annex v restricted to the aspects of manufacture concerned withsecuring gs. Please find the latest consolidated ivdd 98 79 ec below.
For the purpose of issuing the residence permit or document, the member state may require only that the applicant present a valid identity card or passport and provide proof that he or she meets the conditions laid down in article 1. Guidance on the interpretation and application of council. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. 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. 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. The technical report conforms with the protection requirements of the directive 89336 eec article 4.
The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Technical construction file code 3afe 63984612 rev c to which this declaration relates has been assessed by the competent body fimko ltd. Directive 93 68 ec introduced the harmonized provisions related to ce marking. Guidance document on the ppe transition from directive 89686 eec to regulation eu 2016425 faq document 393 kb implementation of article 47 101 kb approval decisions based on ec typeexamination certificates 102 kb validity of an ectype examination certificate and revision of harmonised standards 100 kb. Council directive 9368eec of 22 july 1993 amending. 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 non. 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. Council of 25 october 2011 on consumer rights, amending council directive 93 eec and directive 199944ec of the european parliament and of the council and repealing council directive 85577 eec and directive 977ec of the european parliament and of the council, oj l 304, 22. This document is meant purely as a documentation tool and. You can download the complete directive in pdf by cliquing. Ce marking has been introduced by the council directive 9368eec of 22 july 1993. Directive 7323eec4 was adopted by the council on 19 february 1973 with the aim of harmonising the laws of the member states relating to electrical equipment designed for use within certain voltage limits. Please find the latest consolidated ivdd 9879ec below. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.
European commission dg entri4 2 toys only essential safety requirements defined in the directive detailed technical specifications in. May 1989, as amended by directive 9231 eec dated 28. Council directive 93 68 eec 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. Directive of appliances burning gaseous fuels appligas 2001 commission communication in framework of impl appligas directive 90396 eec. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998. Medical devices directive 93 42 eec personal protective equipment directive 89686 eec as of 21 april 2018 replaced by the personal protective equipment regulation regulation eu 2016425 construction products regulation regulation eu no 3052011. Ec declaration of conformity directive 7323 eec, 93 68 eec document code 00109155.
Directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. July 1993 came into force in all territories of the european union eu on 1. Council directive 9368eec of 22 july 1993 amending directives. Low voltage directive 7323eec council directive of 19 february 1973 on the harmonization of the laws of member states relating to electrical equipment designed for use within certain voltage limits 7323 eec explanatory part of the screening 1620 january 2006 in brussels. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Council directive 9368eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction. The changes outline requirements of the ce mark, to be. 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.
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. 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. M1 council directive 93 42 eec of 14 june 1993 l 169 1 12. Introduction1 the objective of this document is to clarify certain matters and procedures referred to 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. Provisions of directive 200747ec directive 200747ec amends directive 90385 eec on active implantable medical devices and directive 93 42 eec on medical devices. Decision of 14 july 1993 not yet published in the official. 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. Toys directive 88378 eec of 3 may 1988 as amended by 93 68 eec of 22 july 1993. Commission staff working document impact assessment accompanying the document proposals for directives of the european parliament and of the council 1 amending council directive 93 eec, directive 986ec of the european parliament and of the council, directive 200529ec of t he european parliament and of the. 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. Pdf technical guidance document on risk assessment in. This document is meant purely as documentation tool and the institutions do not assume any liability for its contents b council directive 93 68 eec of 22 july 1993 amending directives 87404 eec simple pressure vessels, 88378 eec safety of toys, 89106 eec. B council directive 9342eec of 14 june 1993 concerning.
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