Classification criteria definitions for the classification. Eu medical devices directive m5 amendment 93 42 eec. Articles 6 and 7 of directive 93 preclude a provision of national law, such as the fourth transitional provision of. The ce marking directive 9368eec ce marking association. The court of justice delivered today its judgment in case c. Whereas, in decision 90683eec of december 1990 concerning. The directive 93 68eec details the specific changes to each individual directive in articles 2 to. Directiva 93 cee a consiliului din 5 aprilie 1993 privind clauzele abuzive in contractele incheiate cu consumatorii. The requirements of the european directive on electromagnetic compatibility emc no. Read online b council directive 9342eec of 14 june 1993 concerning. It can be distinguished from regulations, which are selfexecuting and do not require any implementing measures. Eu directive 9342eec, transposed into italian law by italian legislative decree no. Council directive 93 42eec 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. 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.
Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. Medical devices directive 9342eec requirements for. A directive is a legal act of the european union which requires member states to achieve a particular result without dictating the means of achieving that result. This document is meant purely as a documentation tool and. Council decision of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives. May 19, 2010 bsi british standards presentation of eu medical devices directive m5 amendment 93 42 eec regulatory updates. Understanding the medical devices directive 9342 eec directive 9342eec 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.
Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Council directive 9338eec of 14 june 1993 coordinating. Application of the classification rules shall be governed by the intended purpose of the devices. 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 presented by the commission pursuant to article 250 2 of the ec treaty. Council directive 9342eec of 14 june 1993 concerning medical. Micromega products comply with european standard directive 9342 cee and are ce marked. Normally intended for continuous use for more than 30 days. Council directive 9385eec of 4 october 1993 on the. All books are in clear copy here, and all files are secure so dont worry about it. Whereas it is the responsibility of the member states to.
University of groningen ecj 26 october 2006, case c16805. The lvd covers health and safety risks on electrical equipment operating with an input or. Directive 979ec of the european parliament and of the council of 3 march 1997 on investorcompensation schemes the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 57 2 thereof, having regard to the proposal from the commission1. Directive 93 and its applicability to provisions in general terms and conditions. Directiva 93 cee a consiliului din 5 aprilie 1993. From article 2 to article detailed amendments were given, throughout from article 2 to article, to the 12 council directives listed in article 1. Council directive 93104ec of 23 november 1993 concerning certain aspects of the organization of working time official journal l 307, 121993 p. The social cost of the large number of accidents caused by the use of machinery can be reduced by. 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. 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. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts.
The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. Socomec diris a40 operating instructions manual pdf download. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Council directive 93eec of 5 april 1993 on unfair terms in consumer.
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. The medical device regulation of the european union intensifies. View online operators manual for husqvarna fs 6600 d saw or simply click download button to examine the husqvarna fs 6600 d guidelines offline on your desktop or laptop computer. 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. Council directive 93104ec of 23 november 1993 deepdyve. Directive 93 cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. 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. Understanding the machinery directive 2006 42ec the directive has been put in place because. 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, oj l 304, 22. Directive 93 is, according to article 31t ec, a measure which is essential for the accomplishment of the tasks entrusted to the community and, in particular, for the functioning of the internal market. European medical device directive essential requirements checklist. The directive 9368eec details the specific changes to each individual directive in articles 2 to. Page 2 this equipment complies with the requirements of directive 89336eec as amended by 9368eec. Directive 93 103ec work on board fishing vessels of 23 november 1993 concerning the minimum safety and health requirements for work on board fishing vessels thirteenth individual directive within the meaning of article 16 1 of directive 89391eec.
Husqvarna fs 6600 d saw operators manual pdf viewdownload. Pdf ecj 26 october 2006, case c16805 mostaza claro v. Read council directive 93104ec of 23 november 1993, international journal of comparative labour law and industrial relations on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. The low voltage directive is a total harmonisation directive in the sense that it has superseded existing national regulations in the field covered. Member states must notify national measures going beyond the minimum harmonisation of the directive on unfair contract terms 93eec. European medical device directive essential requirements. Ce marking and european medical device directive 9342cee. Directive 93 and its applicability to provisions in. The ce marking logo free download ce mark logo download of the ec rep symbollogo. Presented at the hktdc hong kong international medical devices and supplies fair 2009. Council directive 89391eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Direttiva 93 cee del consiglio, del 5 aprile 1993, concernente le clausole abusive nei contratti stipulati con i consumatori. This table reflects information which the member states have notified to the commission under article 8a of the directive. 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.
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. Unfair terms in consumer contracts directive 1993 wikipedia. Council directive 93104ec of 23 november 1993 concerning. The low voltage directive lvd internal market, industry. Download b council directive 9342eec of 14 june 1993 concerning. From article 2 to article detailed amendments were given, throughout from article 2 to article , to the 12 council directives listed in article 1. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Directive 93103ec work on board fishing vessels of 23 november 1993 concerning the minimum safety and health requirements for work on board fishing vessels thirteenth individual directive within the meaning of article 16 1 of directive 89391eec. Ce marking and european medical device directive 9342 cee. The unfair terms in consumer contracts directive 93eec is a european union directive. 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. Directive 93eec, directive 986ec of the european parliament and of the council, directive 200529ec of t he european parliament and of the council and directive 201183eu of teh european parliament and of the council as regards better enforcement and modernisation of eu consumer.
May 02, 2010 the landscape of european consumer law is changing. This document is meant purely as a documentation tool and the. 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 presented by the commission pursuant to article 250 2 of the ec treaty. Report from the commission on the implementation of council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. If the device is intended to be used in combination with another device, the. Manual on borderline and classification in the community regulatory. Disinfettanti e sterilizzanti a freddo per dispositivi medici invasivi e non invasivi. Directive 9368eec amending directives 89392eec machinery atex directives. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100 a thereof. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. 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. Rayplicker is a class i medical device, bearing the ce marking in accordance with the 9342 cee directive. 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.
The low voltage directive lvd 201435eu ensures that electrical equipment within certain voltage limits provides a high level of protection for european citizens, and benefits fully from the single market. Council directive 9385eec of 4 october 1993 on the control of potato ring rot the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 43 thereof, having regard to the proposal from the commission1. Page 53 iec 6205323 classe 2 marcado ce the diris a40a41 complies with. Guidance on the interpretation and application of council. B council directive 9342eec of 14 june 1993 concerning. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Directive 93103ec work on board fishing vessels safety.
Sorry, we are unable to provide the full text but you may find it at the following locations. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs 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, in cooperation with the european parliament 1. B council directive 9343eec of 14 june 1993 on the. In october 2008, the european commission presented a proposal for a directive on consumer rights, which aims at revising the doorstep selling directive 85577eec, the distance selling directive 977ec, the consumer sales directive 199944ec and the unfair contract terms directive 93 eec.
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