The directive 9368eec details the specific changes to each individual directive in articles 2 to. Europa enterprise guidelines on the implications of the. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. The directive has the dual aim of harmonising the health and safety requirements applicable to machinery on the basis of a high level of protection of health. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts. Directive as last amended by directive 89440eec oj no l 210, 21. Official journal no page date m1 council directive 93 42 eec of 14 june 1993 l 169 1 12.
European medical device directive essential requirements. Essential requirements annex i, 9342eec as compliance. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Council directive 9342eec of 14 june 1993 concerning medical devices. Proposal for a directive of the european parliament. 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 9343eec on the hygiene of foodstuffs. Directive of the european parliament and of the council on the harmonisation of the laws, regulations and administrative provisions of the member states concerning credit for consumers repealing directive 87102ec and modifying directive 93 ec 1. 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. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Regulation ec no 7642008 of the european parliament and of the council of 9 july 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in. Council directive 9315eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses.
Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Council directive 9398eec of 29 october 1993 harmonizing the term of protection of and certain related rights. European, legislation eu, eu directives, 1993 legislation eu eu. The primary purpose of the directive is to develop a single market in explosives through the harmonisation of product safety standards. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules. Directive 201183eu of the european parliament and of the. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts.
Council directive 93 15 eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses description. Whereas it is the responsibility of the member states to. 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 93eec of 5 april 1993 on unfair terms. Because of the many types of devices covered by the mdd, the specific requirements depend on the. In order to facilitate the application of council directive 93eec on unfair contract terms in consumer contracts uctd, on the 22nd july.
Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. 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. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. This declaration is based on the pf50 technical file, established in accordance with the appendix vii demonstrating the conformity of the product to the standards of the directive 9342eec and in particular to the essential requirements. B council directive 9342eec of 14 june 1993 concerning. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12.
Directive harmonising the term of protection of and certain related rights. Part ii directive 988ec of the european parliament and of the council concerning the placing of biocidal products on the market commission regulation ec no 148894 on risk assessment for existing substances commission directive 9367eec on risk assessment for new notified substances in support of tgd part ii institute for health and. Ec declaration of conformity directive 7323eec, 9368eec document code 00109155. 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. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs.
A slight difference exists between the definition in article 12 a of directive 93 42 eec and in article 12 of directive 90385 eec. Unfair contract terms directive european commission. Guidance on the interpretation and application of council directive. In the years folowing entry into force of the directive, although efsa has not. Directive as last amended by directive 88295eec oj no l 127, 20. 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 official journal l 165, 07071993 p. Dropbox, icloud and 4 webbased software applications e. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our. A slight difference exists between the definition in article 12 a of directive 9342eec and in article 12 of directive 90385eec. Cjeu on articles 6 and 7 directive 93 european civil. Hse states that the explosives manufacturers will not incur any additional costs from having to include conformity attestation on explosives as this information is already contained in the product label. Directive 201183eu of the european parliament and of the council of 25 october 2011 on consumer rights, amending council directive 93eec and directive 199944ec of the european parliament and of the council and repealing council directive 85577eec and directive 977ec of the european parliament and of the council text with eea relevance. The ce marking directive 9368eec ce marking association. This document is meant purely as a documentation tool and the.
This document is meant purely as a documentation tool and. Unfair contract terms directive, council directive 93 eec of 5 april 1993 council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts the council of the european communities, whereas it is necessary to adopt measures with the aim of progressively establishing the internal market before. Following the latter directive, accessories are by definition medical devices, whilst following directive 93 42 eec, a distinction is made between devices and. This directive shall apply to explosives as defined in paragraph 2. The unfair contract terms directive 93eec protects consumers against unfair standard contract terms imposed by traders. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385 eec oj l 189, 20.
State of procedure the proposal com 2002 443 final 20020222 cod was adopted by the. Eu directives are being published on this site to aid cross referencing from uk legislation. 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. Directive 201183eu of the european parliament and of the council of 25 october 2011on consumer rights, amending council directive 93eec and directive 199944ec of the european parliament and of the council and repealing council directive 85577eec and directive 977ec of the european parliament and of the 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 council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 57 2 thereof, having regard to the proposal from the commission 1, in cooperation with the european. Council directive 89391eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Commission directive 93112ec amending commission directive 91155eec defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of article 10 of directive 88379eec citation. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts to see the original english version of this document, please, follow the link.
Directive of appliances burning gaseous fuels appligas 2001 commission communication in framework of impl appligas directive 90396 eec. Please enter a short name of your company so that we can allocate the documents you submitted. Medical device directive mdd 93 42 eec as modified by 200747ec. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec oj l 189, 20. Directive 200642ec is a revised version of the machinery directive, the first version of which was adopted in 1989. Unfair terms in consumer contracts directive 1993 wikipedia. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Directive whereas the consumer mustreceive equal protection. Commission guidance on the interpretation and application of the. We abb industry oy hiomotie , finoo381 helsinki, finland declare under our sole responsibility that the product. It applies without prejudice to more specific community food hygiene regulations. Following the latter directive, accessories are by definition medical devices, whilst following directive 9342eec, a.
Council directive 9315eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses description. Directive of efficiency of liquid or gaseous fueled hot water boilers. Directive 201183eu of the european parliament and of the 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 85577eec and directive 977ec of the european parliament and of the council text with eea relevance. Transposition of the recast of directive 9315eec directive 201428eu. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Council directive 9338eec of 14 june 1993 coordinating. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Council directive 93eec of 5 april 1993 on unfair terms in consumer. The amendments to the mdd has been published a number of additional directives amending the original directive has been introduced, the recent revising directive 200747 ec is amending of the directive 90385eec concerning active implantable medical devices, directive 9342eec concerning medical devices and directive 988ec concerning the. Commission directive 93 112ec amending commission directive 91155 eec defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of article 10 of directive 88379 eec citation. Ec declaration of conformity directive 7323eec, 9368eec. 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. Contents of technical documentation for mdd 9342eec and.
Guide to application of the machinery directive 200642ec. Article 71 of council directive 93 precludes national legislation. Other applicable directives and regulations description of all applicable directive s and regulations e. Article 1 of the medical devices directive 9342eec nrlcontaining medical devices i. Council directive 93eec of 5 april 1993 on unfair terms in. Application for performancechangeextension of a conformity. The unfair terms in consumer contracts directive 93eec is a european union directive then called european economic community directive governing the use of surprising or onerous terms used by business in deals with consumers.
Europa enterprise guidelines on the implications of. Directive 93eec unfair contract terms directive better. This represents the minimum standard a manufacturer is expected to. Please find the latest consolidated ivdd 9879ec below. To see the original english version of this document, please, follow the link. The unfair terms in consumer contracts directive 93 eec is a european union directive then called european economic community directive governing the use of surprising or onerous terms used by business in deals with consumers. Other applicable directives and regulations description of all applicable directives and regulations e. Directive of appliances burning gaseous fuels appligas 2001 commission communication in framework of impl appligas directive 90396eec. Directive of the european parliament and of the council on the harmonisation of the laws, regulations and administrative provisions of the member states concerning credit for consumers repealing directive 87102ec and modifying directive 93ec 1.
The ivd directive was amended and corrected over time. Medical device directive mdd 9342eec as modified by 200747ec. After exit day no further amendments will be applied to this. 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. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts to see the original english version of this document, please, follow the link. Directive 9342eec into the french national legislation. The court of justice delivered today its judgment in case c. Councildirective93 eec 5 of1993 april on unfair termsin consumer contracts. The new machinery directive has been applicable since 29th december 2009. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.
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