The medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. Council directive 9242eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Council directive 9368eec of 22 july 1993 amending. Council directive 92118eec of 17 december 1992 laying down animal health and public health requirements governing trade in and imports into the community of products not subject to the said requirements laid down in specific community rules referred to in annex a i to directive 89662eec and, as regards pathogens, to directive 90425eec. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. The council of the european communities, having regard to the treaty establishing the european economic community, and in. The mdr is a fundamental revision of the earlier directives and is intended to establish a. Objectivethis directive lays down the minimum requirements for improving the safety and health protection of workers in the mineralextracting industries through drilling i. Council directive 9251eec of 18 june 1992 on a second. How are medical devices regulated in the european union.
B council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425 eec oj l 268, 14. 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. Council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities. At the end of the course, you will be able to implement the requirements of the directive. Council directive 92 49 eec of 18 june 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and amending directives 73239 eec and 88357 eec third nonlife insurance directive. The social cost of the large number of accidents caused by the use of machinery can be reduced by. Eu 12 energy labelling of household appliances directive 9275ec general description council directive 9275eec of 22 september 1992 on the indication by labelling and standard product information of the consumption of energy and other resources of household appliances is the basic. Council directive 92 32 eec of 30 april 1992 amending for the seventh time directive 67548 eec on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Council directive 9246ec laying down the health rules for. This document is meant purely as a documentation tool and. Council directive amending directive 9283eec on the.
Directive 200532ec of the european parliament and of the. Article 2 for the purposes of this directive, the definition of medi cinal products set out in article 1 2 of council directive 656s eec f, and the definition of veterinary medicinal products set out in article 1 2 of directive 8 1851 eec, shall apply. View pdf council directive 9242eec of 21 may 1992 on efficiency requirements for. Directive of the european parliament and of the council 200441ec repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending council directives 89662 eec and 92 118 eec and council decision 95408ec. Council directive 9343eec on the hygiene of foodstuffs. In order to ensure the survival of europes most endangered and vulnerable species, eu governments adopted the habitats directive in 1992 council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora.
Adopted in 1992, the council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna. Council directive 92 24 eec of march 31, 1992 relating to speed limitation devices or similar speed limitation onboard systems of certain categories of motor vehicles. In view of the breadth of the scope of the directive and the variety of products covered, it. Council directive 92 35 eec of 29 april 1992 laying down control rules and measures to combat african horse sickness official journal l 157, 10061992 p. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Council directive 92 100 eec of 19 november 1992 on rental right and lending right and on certain rights. B council directive 9265eec of july 1992 laying down. 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.
Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereofhaving, regard tothe proposalfromthe commission. Together with the birds directive, it sets the standard for nature conservation across the eu and enables. The english version of the directive 9242eec on efficiency. Official journal no page date m1 council directive 93 42 eec of 14 june 1993 l 169 1 12. Pay securely by credit card and your documents are delivered directly and immediately to your computer. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. If youre a hotwater boiler manufacturer or distributor you need to ensure products meet the essential requirements of the directive before the ce marking is applied. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission. Medical devices directive 93 42 eec annex ii full quality assurance annex v production quality assurance. Council directive 92 22 eec of march 31, 1992 on safety glazing materials on motor vehicles and their trailers. This item of legislation is only available to download and view as pdf. Council directive 92 42 eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Directive 92 31 eec of 28 april 1992 l 126 of 12 may 1992, p. Council directive 9229eec of 31 march 1992 on the minimum safety and health requirements for improved medical treatment on board vessels the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 118a thereof.
Council directive 93 42 eec 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. Active implantable medical devices directive 90385eec. The revision of the medical devices directive 9342eec. Nol 1692 official journalofthe europeancommunities. Evaluation of council directive 92 83 eec european commission 5.
Directive of the european parliament and of the council of 5th september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of biocidal prodcuts on the. Council directive 9258eec of 24 june 1992 on the minimum requirements for the provision of safety andor health signs at work ninth individual directive within the meaning of article 16 1 of directive 89391eec the council of the european communities, having regard to the treaty establishing the european economic community, and in. Council directive 92 101 eec of 23 november 1992 amending directive 7791 eec on the formation of public limited liability companies and the maintenance and alteration of their capital. Council directive 92 100 eec of 19 november 1992 on rental right and lending right and on certain rights related to in the field of intellectual property is a european union directive in the field of law, made under the internal market provisions of the treaty of rome. Directive 92104eec mineralextracting industries safety. Pay securely by credit card and your documents are delivered directly and immediately to your computer as pdf files. Title compliance with medical device directive 98 42 eec mdd description the course is designed to give you an understanding of the requirements of the medical device directive 93 42 eec as amended in 200747ec. Equipment for potentially explosive environments directive 201434eu. Understanding the machinery directive 2006 42 ec the directive has been put in place because. Objectivethis directive lays down the minimum requirements for improving the safety and health protection of workers in surface and underground mineralextracting industries except for the mineral extracting industries through drilling which is governed by directive 92 91 eec.
Council directive 93 42 eec of 14 june 1993 concerning medical devices. Reduced rates for lowstrength alcoholic products 5. Council directive 9258eec of 24 june 1992 on the minimum. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to. Directive 200532ec of the european parliament and of the council of 6 july 2005 establishing a framework for the setting of ecodesign requirements for energyusing products and amending council directive 92 42 eec and directives 9657ec and 200055ec of the european parliament and of the council repealed. Council directive 92 42 eec of 21 may 1992 on efficiency. 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. There are changes that havent been incorporated into the text of this council directive 9368 eec. Rental of computer programs this directive shall be without prejudice to article 4 c of council directive 91250 eec of 14 may 1991 on the legal protection of computer programs 5. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Council directive 92 12 eec of 25 february 1992 on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such products. Essential requirements are part of the technical file or design dossier. B council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora oj l 206, 22. Please find the latest consolidated ivdd 9879 ec below.
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 council of the european communities, having regard to the treaty establishing the european economic community, and in particular article s thereof. Council directive 92 100 eec of 19 november 1992 on rental right and lending right and on certain rights related to in the field of intellectual property. Council directive 92118eec of 17 december 1992 laying down.
In deciding whether a product falls under directive 93 42 eec or under directive 89686 eec, particular account shall be taken of the principle. The directive is one of the measures implementing the ecodesign of energy related products directive 2009125ec which sets out efficiency requirements for. B council directive 9343eec of 14 june 1993 on the hygiene. Habitats directive conservation environment european. Council directive 92101eec of 23 november 1992 amending. 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. Compliance with medical device directive 9842eec mdd. Council directive 9265eec of july 1992 laying down. Technical file for all classes of medical devices i, iia, iib, iii the manufacturer must have and keep uptodate a technical documentation, also called a technical file or a device master file. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. Following article 16 of directive 93 42 eec, this directive does not apply to personal protective equipment covered by directive 89686 eec relating to personal protective equipment 4.
While a proposal to amend directive 92 84 eec may reduce the incentive for tax evasion and positively impact. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Directive 92 42 eec covers the efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Some 200 rare and characteristic habitat types are also targeted for conservation in their own right. It concerns the basic rights of people before and after pregnancy in the european union. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Boiler efficiency directive 9242 eec what does it mean for you. Directive 9242eec covers the efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Directive 2006 42 ec is a revised version of the machinery directive, the first version of which was adopted in 1989. This documentation demonstrates compliance with essential requirements annex i of the 93 42 eec.
Official journal no page date m1 council directive 9762ec of 27 october 1997 l 305 42 8. Article 15 thereof, namely council directive 9242eec of 21 may 1992 on efficiency requirements for new hot water boilers fired with liquid or. Click here to purchase the full version from the ansi store. Council directive 9232eec of 30 april 1992 amending for. The ivd directive was amended and corrected over time. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. 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 9232eec of 30 april 1992 amending for the. Council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425 eec. Council directive 9242eec of 21 may 1992 on efficiency. Council directive 9246eec of 16 june 1992 laying down the health rules for the production and placing on the market of raw milk, heattreated milk and milkbased products the council of the european communities, the council of the european communities, having regard to the treaty establishing the european economic community, and in particular.
Legal instrument directive treaty european economic community publication ref. As from 1 january 1993, the minimum rate of excise duty on alcohol and alcohol contained in beverages other than those referred to in articles 4, 5 and 6 shall be fixed at ecu 550 per hectolitre of pure alcohol. Directive as last amended by directive 92 27 eec oj no l 1, 30. The habitats directive environment european commission. Guide to application of the machinery directive 200642ec 2nd edition june 2010 1 introduction to the 2nd edition directive 200642ec is a revised version of the machinery directive, the first version of which was adopted in 1989. Ce mark tcf technical construction file file sample. Directive 9242eec of 21 may 1992 on efficiency requirements for. Council directive 926eec of 10 february 1992 on the. Member states shall assess the guides to good hygiene practice referred to in paragraphs 1 and 2 with a view to determining the extent. Council directive 9229eec of 31 march 1992 on the minimum. The new machinery directive has been applicable since 29th december 2009. Council directive 9235eec of 29 april 1992 laying down.
Definitions the terms mineralextracting industries through drilling and workplace are defined. Guide to application of the machinery directive 200642ec. Directive handbook electromagnetic compatibility directive. Medical device directive mdd 93 42 eec as modified by 200747ec. 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. B council directive 9342eec of 14 june 1993 concerning. Instead, they are listed below for reference and previous revised dated versions are available on more resources. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Directive as last amended by directive 87403 eec oj no l 220, 8. Whereas council directive 8948 eec of 21 december 1988 on a.
Without prejudice to the rules on movement laid down in directive 92 12 eec member states need not consider establishments for the production of mieral oils those establishments in which the only products manufactured are mineral oils for which a level of duty is not specified by directive 92 82 eec. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. Council directive 92 29 eec of 31 march 1992 on the minimum safety and health requirements for improved medical treatment on board vessels official journal l 1, 30041992 p. Environmental design for energyrelated products directive 2009125ec. Council directives 90385eec and 9342eec, will consolidate two existing legal provisions and replace both the current medical device directive 9342eec and the active implantable medical device directive 90385eec. The habitats directive ensures the conservation of a wide range of rare, threatened or endemic animal and plant species. Council directive 92 6 eec of 10 february 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the community. Bsi are a notified body for the boiler efficiency directive and can help manufacturers comply with this directive and gain fast access to the european market.
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