The directive also requires that the symbols, indications of danger, r and sphrases to be used for each substance shall be those shown in annex i article 232c, d and e. 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. 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. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our sole responsibility that the product. Ce marking and european medical device directive 93 42cee. Council directive 9342eec of 14 june 1993 concerning medical devices. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Commission directive 9349eec of 23 june 1993 setting out. Construction products directive council directive 89106eec cpd is a now repealed. Directive 201430eu of the european parliament and of the council of 26 february 2014 on the harmonisation of the laws of the member states relating to electromagnetic compatibility recast. L 9112 en official journal of the european communities 7.
B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. 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 has been introduced by the council directive 93 68eec of 22 july. 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. Council directive 9343eec on the hygiene of foodstuffs. Switzerland, which is a member of efta but not of the eea. Also, ce mark which is attached to our companys products of battery operated apparatus means it conforms to emc directive 89336eec and.
The ce marking directive 9368eec ce marking association. Medical devices internal market, industry, entrepreneurship. The main objective of the emc directive is to guarantee the free movement of. 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 7323eec oj l 77, 26. 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. Ce marking is a certification mark that indicates conformity with health, safety, and. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules. Di rective as last amended by directive 9368eec oj no l 220, 30. 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. In view of the breadth of the scope of the directive and the variety of products covered, it.
These regulations contain the legislative measures necessary for the implementation of three european community directives. 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. Council directive 93 96 eec of 29 october 1993 on the right of residence for students extends the right of residence to students and their family members. Interface machinery directive lvd article 15 of machinery directive 9837ec. 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 directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs. Article 4 of directives 90364 eec and 90365 eec and article 5 of directive 93 96 eec lay down the obligation of the european commission to draw up a report on. Active implantable medical devices directive 90385eec. Annex i to consolidated version of directive 67548eec. The scf report covers all of the vitamins and minerals listed in directive 200115eec foods for particular nutritional use, directive 200246eec food supplements, and in the draft proposal on the addition of vitamins and minerals. Council directive 9368eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction.
Ce marking and european medical device directive 9342cee. Within the community, the free movement of electrical equipment should follow. Directive 200070ec of the european parliament and of the council of 16 november 2000. F2 substituted by commission implementing directive eu 2020177 of 11 february 2020 amending council directives 66401 eec, 66402 eec, 68 193 eec, 200255ec, 200256ec and 200257ec, commission directives 93 49 eec and 93 61 eec and implementing directives 201421eu and 201498eu as regards pests of plants on seeds and other plant. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. 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. Council directive 9338eec of 14 june 1993 coordinating the. Council directive 9398eec of 29 october 1993 harmonizing the term of protection of and certain related rights. These guidelines are intended to be a manual for all parties directly or indirectly.
Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. Council directive 9342eec concerning medical devices, as amended. 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 9398ec with amendments that is in force since 2007. Ce directives pdf active implantable medical devices directive 90385eec cableway installations directive 20009ec construction products regulation 3052011eu. You can find all the info you need by filtering by directive, andor enabling or disabling the synonyms search. 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. Eec council directive 9368eec of 22 july 1993 ce logo. 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. Also, ce mark which is attached to our companys products. Directive 90496eec on nutrition labelling for foodstuffs. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 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 stable derivates of human. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.
Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Ce marking ce mark for appliances burning gaseous fuels. Official journal no page date m1 council directive 93 68 eec of 22 july 1993 l220 1 30. The ivd directive was amended and corrected over time. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our. The directive 93 68 eec details the specific changes to each individual directive in articles 2 to. The cpd has been amended by the council directive 9368eec of 22 july 1993 and. Council directive 9368eec 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. Published 1989 in force since 1992 mandatory since 1996. 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. Search for an harmonised standard using the most powerful standard search engine on the web.
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. You can download the complete directive in pdf by cliquing. It sought to ensure the free movement of all construction products within the european union by. The citizens rights directive 200438ec also sometimes called the free movement directive defines the right of free movement for citizens of the european economic area eea, which includes the member states of the european union eu and the three european free trade association efta members iceland, norway and liechtenstein. Council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. Article 22 subparagraphs 2 and 3 of directive 9396eec provides that the provisions of articles 2, 3 and 9 of directive 68360eec and articles 2 to 9 of directive 64221eec shall apply to the holders of the right of residence according to directive 9396eec. For substances belonging to one particular group of substances included in annex i, the symbols, indications of danger, r. Council directive 93eec of 5 april 1993 on unfair terms. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by directive 7323eec where, in the case of machines, it cannot be established that the risks are mainly of electrical origin, both the. Please find the latest consolidated ivdd 9879ec below. Annex 1 provides a comparison between the figures proposed by the scf and those in. Pressure equipment directive content pressure equipment directive.
The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. 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. Ec declaration of conformity directive 7323eec, 9368eec document code 00109155. 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. F2 substituted by commission implementing directive eu 2020177 of 11 february 2020 amending council directives 66401eec, 66402eec, 68193eec, 200255ec, 200256ec and 200257ec, commission directives 9349eec and 9361eec and implementing directives 201421eu and 201498eu as regards pests of plants on seeds and other plant. It applies without prejudice to more specific community food hygiene regulations. And, ce mark which is attached after january 1, 1997 means it conforms to emc directive 89336eec, ce mark directive 9368eec and low voltage directive 73 23eec.
Council directive 9338eec of 14 june 1993 coordinating. 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 directive 93 42 eec concerning medical devices, as amended. B council directive 9342eec of 14 june 1993 concerning. The construction products directive 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. Europa guidelines on the application of directive 200695ec. Official journal no page date m1 council directive 9368eec of 22. 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. Directive 9368ec introduced the harmonized provisions related to ce marking. 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. Ec declaration of conformity directive 7323eec, 9368eec.
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