The 2nd british standard for antid rh o antibodies consists of. The european directive 9879ec on in vitro diagnostic. The labelling directive requires manufacturers to declare all ingredients present in prepackaged foods sold in the eu with very few exceptions. Directive 200941ec recasting directive 90219eec lays down common measures for the contained use of gmms with a view to protecting human health and the environment. Guidance explaining the main features of the in vitro diagnostic medical devices directive 9879ec. Directive 200615ec indicative occupational exposure limit values of 7 february 2006 establishing a second list of indicative occupational exposure limit values in implementation of council directive 9824ec and amending directives 922eec and 200039ec.
The ce marking directive 9368eec ce marking association. In all other territories this product can be used for research purposes only. After a stepwise introductory period of five years it will come into full power for placing on the market by december 7, 2003 with all its rules and amendments. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the commission 1. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices article 1 scope, definitions 1. Directive 9827ec of the european parliament and of the council of 19 may 1998 on injunctions for the protection of consumers interests the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof. X3 inserted by corrigendum to directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices official journal of the european communities l 331 of 7 december 1998. The eec framework directive for health and safety at workt introduction european commission president jacques delors has acknowl edged that inclusion of western european labor unions in the 1992 changes is necessary to avert a working class backlash to the single market. Ce marking ce mark for in vitro diagnostic medical devices.
Directive 89391eec osh framework directive sicherheit. Commission directive 2014 79 eu of 20 june 2014 amending appendix c of annex ii to directive 200948 ec of the european parliament and of the council on the safety of toys, as regards tcep, tcpp and tdcp. Current regulatory framework of in vitro diagnostic medical. Directive 200070 ec pdf, 106 kb of the european parliament and of the council of 16.
In vitro diagnostic medical devices internal market. Council directive 9857ec on the control of ralstonia. Directive 9827ec of the european parliament and of the of. This directive shall apply to in vitro diagnostic medical devices and their accessories. Council directive 89391eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Directive 949ec of the european parliament and the. The ivdd aims to supplement the legal framework of the. Verification of manufactured products for the ivd directive. Council directive 9859 ec of 20 july 1998 on the approximation of the laws of the member states relating to collective redundancies official journal l 225, 12081998 p.
Intended use this product is ce marked for use as an ivd within the eu member states and eea countries. Directive 98 48 ec of the european parliament and of the council of 20 july 1998 amending directive 98 34 ec laying down a procedure for the provision of information in the field of technical standards and regulations the provisions of directive 98 34 ec which have been modified by. The eec framework directive for health and safety at work. Directive 200112ec, amending directive 91440eec and providing for the openingup to competition of the 50,000 km transeuropean rail freight network from 2003, and of other international freight routes from 2008, directive 2001ec, amending directive 9518ec and extending the licensing principle to allsector undertakings. Directive 199992 ec of the european parliament and of the council of 16 december 1999. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices this document comes with our free notification service, good for. Directive as amended by directive 9563 ec ojl335,30.
Directive 9879ec of the european parliament and of the. Council directive 20068ec of 19 december 2006 amending directive 2006112ec on the common system of value added tax as regards the period of application of the value added tax arrangements applicable to radio and television broadcasting. Directive 9879ec since 2000 defines conditions for ivds human entering the common market key players ivd manufacturers competent authorities notified bodies different classes of ivds with different level of third party intervention majority of ivds. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices this document comes with our free notification service, good for the life of the document. Whereas directive 70221eec is one of the separate directives in the ec typeapproval procedure established by council directive 70156eec of 6 february 1970 on the approximation of the laws of the member states relating to the typeapproval of motor vehicles and their trailers 3, as last amended by directive 96 79 ec of the european. Commission directive 9677ec of 2 december 1996 laying down specific purity criteria on food additives other than colours and sweeteners text with eea relevance the commission of the european communities, having regard to the treaty establishing the european community, having regard to council directive 89107eec of 21 december 1988 on the.
Directive 9879ec referred to in this document as the directive. The directive on in vitro diagnostic medical devices ivdd 98 79 ec was officially adopted by the european union eu on december 7, 1998. Ec directive 98 79 ec hereafter abbreviated as 98 79 ec represents a robust and workable regulatory framework based on iso 485 for quality system compliance. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Directive 9768ec of 16 december 1997 european environment. The references published under directive 98 79 ec on in vitro diagnostic medical devices are found in commission implementing decision eu 2020439 of 24 march 2020 oj l 90i, 25 march 2020 listed below. The ivdd is implemented in the national laws of the member states. In vitro diagnostic medical devices directive 9879ec tuv sud. Commission regulation ec no 1822009 of 6 march 2009. This can integrate into a manufacturers existing system and processes to meet the additional regulatory requirements and ensure device compliance. The commission of the european communities, having regard to the treaty establishing the european community, having regard to council directive 91414eec of 15 july 1991 concerning the placing of plant protection products on the market, as last amended by commission directive 9536ec, and in particular article 18 2 thereof. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices article 1 scope, definitions 1. Whereas directive 70221eec is one of the separate directives in the ec typeapproval procedure established by council directive 70156eec of 6 february 1970 on the approximation of the laws of the member states relating to the typeapproval of motor vehicles and their trailers 3, as last amended by directive 9679ec of the european. Directive 949ec of the european parliament and the council of 23 march 1994 author.
Directive 98 79 ec smaller changes 2007 onwards vcjd assays efforts to include vcjd assays into high risk ivds cts and guideline for vcjd assays revision of the cts for high risk ivds. Eurlex the access to european union law and the european. The aim of this recommendation is to define modalities for the verification of manufactured products as required by annex iv 6 and vii 5 of the ivd directive. L 21718 en official journal of the european communities 5. L 33032 en official journal of the european communities 5. The eu ivd directive 98 79 ec a users point of view article downloaded from. The directive on in vitro diagnostic medical devices ivdd 9879ec was officially adopted by the european union eu on december 7, 1998. The labelling directive requires manufacturers to declare all ingredients present in prepackaged foods sold in. Objectivethe aim of this directive is to introduce measures to encourage improvements in the safety and health of workers at work. Information is also presented on how to determine if you require a notified body to assess conformity prior to affixing a ce mark. Uk standards for microbiology investigations issued by the standards unit, public health england suggested citation for this document public health england. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the commission 1. Directive 200615 ec indicative occupational exposure limit values of 7 february 2006 establishing a second list of indicative occupational exposure limit values in implementation of council directive 98 24 ec and amending directives 922eec and 200039 ec.
Ce marking ce mark, eu council directive 89106eec of. The eu ivd directive 9879 ec a users point of view. Regulation ec no 792009 european environment agency. Council directive 89106eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products this directive has been amended by the following council directives. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article. Declaration of conformity for recreational craft propulsion engines with the requirements of directive 9425ec as amended by directive 200344ec name of engine manufacturer. Directive 200437ec carcinogens or mutagens at work. Directive 949ec of the european parliament and the council. Ce marking ce mark, eu council directive 89106eec of 21. Directive 9671 ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services official journal l 018, 21011997 p. The labelling directive directive 2000ec and its later amendments is the only piece of eu legislation that specifically refers to allergenic foods. A subgroup of medical products, their market access, use, and market surveillance is regulated. Directive 9518ec on the licensing of railway undertakings. This directive concerns the measures to be taken within the member states against ralstonia solanacearum smith yabuuchi et al.
Council directive 9518ec of 19 june 1995 on the licensing of railway undertakings official journal l 143, 27061995 p. Directive 949 ec of the european parliament and the council of 23 march 1994 author. Cemarking of premdd devices page 27 vdtuevdocument dn. If you think you may need a notified body, whether your device. Directive 9848ec of the european parliament and of the council of 20 july 1998 amending directive 9834ec laying down a procedure for the provision of information in the field of technical standards and regulations the provisions of directive 9834ec which have been modified by. In conclusion the ce marking directive was responsible for the requirements of attaching a ce mark to product. The references published under directive 9879ec on in vitro diagnostic medical devices are found in commission implementing decision eu 2020439 of 24 march 2020 oj l 90i, 25 march 2020 listed below. Council directive 9883ec of 3 november 1998 on the. Directive 9671ec of the european parliament and of the.
Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Equipment and protective systems intended for use in potentially explosi ve atmospheres keywords. Without prejudice to directive 2000ec and council regulation ec no 5102006, this regulation lays down specific standards for retailstage marketing of the olive oils and olivepomace oils referred to in points. Archive adopted amendments to directive 76769eec dichloromethane in paint strippers amendment of council directive 76769eec decision no 4552009ec of the european parliament and of the coucil of 6 may 2009 14. Directive 200437 ec carcinogens or mutagens at work. Directive 200948 ec should therefore be amended accordingly. Whereas rules on dangerous substances have already been laid down in council directive 67548eec of 27 june 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 4, as last amended by directive 79 831eec 5. The european directive 9879ec on in vitro diagnostic medical devices, or ivd directive. Directive 9768ec of the european parliament and of the council of 16 december 1997 on the approximation of the laws of the member states relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in nonroad mobile machinery. The labelling directive directive 2000 ec and its later amendments is the only piece of eu legislation that specifically refers to allergenic foods. Atex atex is the term used when referring to the european unions eu directive 949ec. Directive 200941ec environmental protection agency. However overtime the directive is now fairly redundant as all of the directives mentioned have either been superseded or amended to include the ce marking requirement along with the details of affixing the ce mark itself. Understanding the in vitro diagnostic medical devices directive 98 79ec in vitro diagnostic medical devices ivds are subject to the european directive 9879ec ivdd.
Directive 200928ec of the european parliament and of the. Regulation ec no 792009 of the european parliament and of the council of 14 january 2009 on typeapproval of hydrogenpowered motor vehicles, and amending directive 200746ec. European directive 9879ecivd is suitable for those medical devices used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine. The market access, use, and market surveillance of in vitro diagnostic medical devices are subject and regulated by the european directive 9879ec ivdd. Directive 200177ec of the european parliament and of the council of 27 september 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market 1 oj l 283, 27. Whereas rules on dangerous substances have already been laid down in council directive 67548eec of 27 june 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 4. The atex directive main objectives are to guarantee the free circulation of goods within the european union by aligning the technical and. It applies to all sectors of activity, both public and private, except for specific public service activities, such as the armed forces, the police or certain civil protection services. Council directive 9883ec of 3 november 1998 on the quality. Annex iv 6 and vii 5 of the ivd directive do not define how the verification of manufactured products should be performed. European directive on in vitro diagnostic medical devices 9879ec. Commission regulation ec no 1822009 of 6 march 2009 amending regulation ec no 10192002 on marketing standards for olive oil the commission of the european communities, having regard to the treaty establishing the european community, having regard to council regulation ec no 12342007 of 22 october 2007 establishing a common organisation. In vitro diagnostic medical devices directive 9879ec.
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