Commission directive of 23 july 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products the commission of the european communities, having regard to the treaty establishing the european economic community, having regard to council directive 81851 eec of 28. There are changes that havent been incorporated into the text of this council directive 9368 eec. 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. Nonbinding guide to good practice for understanding and. Council directive 9342eec of 14 june 1993 concerning medical devices.
This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Boiler efficiency directive 9242 eec what does it mean for you. In view of the breadth of the scope of the directive and the variety of products covered, it. If the appliance is at the same time a medical device within the meaning of directive 93 42 eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this directive. Whereas council directive 8948 eec of 21 december 1988 on a. 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.
Article 5 1 c of directive 7762 eec shall be replaced by the following. 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. 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. 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. Atex directive from wikipedia, the free encyclopedia the atex directive consists of two eu directives describing what equipment and work environment is allowed in an environment with an explosive atmosphere. Council directive 92 42 eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Council directive 92118eec of 17 december 1992 laying down.
Council directive 9243eec on the conservation of natural. 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. Eec council directive 9368 eec of 22 july 1993 ce logo. Atex derives its name from the french title of the 949ec directive. Medical devices directive 93 42 eec try it for free on. B council directive 9265eec of july 1992 laying down. 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. For the purposes of this directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. B council directive 9343eec of 14 june 1993 on the hygiene. The ce marking directive 9368eec ce marking association. Together with the birds directive, it sets the standard for nature conservation across the eu and enables. Guide to application of the machinery directive 200642ec. Council directive 92 42 eec of 21 may 1992 on efficiency.
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. Active implantable medical devices directive 90385 eec. Habitats directive council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora. 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. 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. Proposal for a directive of the european parliament and of. Pursuant to this directive, measures shall be designed and undertaken in order to maintain or restore, as the case may be, natural habitats and species of wild fauna and flora. This site is like a library, you could find million book here by using search box in the header. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the medical device. 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. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 93 42 eec concerning medical devices. Directive 20048ec of the european parliament and of the council of 11 february 2004 on the promotion of cogeneration based on a useful heat demand in the internal energy market and amending directive 92 42 eec the european parliament and the council of the european union, having regard to the treaty establishing the european com. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular articles 75 and 84 2 thereof.
Objectivethis directive lays down minimum safety and health requirements for temporary or mobile construction sites i. 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. There are three medical device directives in place, the directive of active implantable medical devices 90385 eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. 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. Directive 2006 42 ec is a revised version of the machinery directive, the first version of which was adopted in 1989. B 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. Report from the commission to the council, the european parliament, the european economic and social committee and the committee of the regions on the practical implementation of health and safety at work directives 93103ec fishing vessels and 92 29 eec medical treatment on board vessels. Definitions the terms mineralextracting industries through drilling and workplace are defined. Council directive 92 106 eec of 7 december 1992 on the establishment of common rules for certain types of combined transport of goods between member states.
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. This item of legislation is only available to download and view as pdf. Proposal for a directive of the european parliament and of the council on establishing a framework for the setting of eco design requirements for energy using products and amending council directive 92 42 eec com 2003 453 final orgalime position pap er brussels, 5 december 2003. Council directive 92 29 eec 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. Council directive 9232eec of 30 april 1992 amending for the. Strategic environmental assessment directive directive 2001 42 ec of the european parliament and of the council of 27 june 2001 on the assessment of the effects of certain plans and. 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 official journal l 228, 11081992 p. Directive 200642ec is a revised version of the machinery directive, the. Council directive 9368eec of 22 july 1993 amending.
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. 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. Appareils destines a etre utilises en atmospheres explosibles. 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. The aim pursued by this directive is to ensure biodiversity through the conservation of natural habitats and of wild fauna and flora in the territories of the member states. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. B council directive 9342eec of 14 june 1993 concerning. It concerns the basic rights of people before and after pregnancy in the european union.
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 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 official journal l 228. Council directive 9246eec of 16 june 1992 laying down the. Council directive 92 50 eec of 18 june 1992 relating to the coordination of procedures for the award of public service contracts. Council directive 9265eec of july 1992 laying down.
Directive 9257eec temporary or mobile construction sites. Adopted in 1992, the council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora aims to promote the maintenance of biodiversity, taking account of economic, social, cultural and regional requirements. Habitats directive conservation environment european. Directive of general products safety for all products 9368 eec. Directive 20048ec of the european parliament and of the council of. Council directive 9251 eec of 18 june 1992 on a second general system for the recognition of professional education and training to supplement directive 8948eec official journal no l209 p. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Environmental design for energyrelated products directive. 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 92106eec of 7 december 1992 on the. 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 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, having regard to the treaty establishing the european economic community, and in particular article 43 thereof.
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. The medical device directive is intended to harmonise the laws relating to medical devices. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to. Production equipment, capital goods and other products used exclusively in the context. 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. Habitats directive council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild. Council directive 9242eec of 21 may 1992 on efficiency. L 17167no the councilof theeuropean,communities council. Council directive 9242eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Normally intended for continuous use for more than 30 days. Directive 9283eec hereafter referred to as the directive defining inter alia, excise categories, the scope for reduced rates and exemptions while directive 9284eec fixes minimum rates for alcohol. Council directive 9343eec on the hygiene of foodstuffs. Read online list of bodies notified under directive.
Council directive 92 59 eec of 29 june 1992 it is necessary to establish on a community level a general safety requirement for any product placed on the market that is intended for consumers or likely to be used by consumers. Directive 200828ec of the european parliament and of the council of 11 march 2008 amending directive 200532ec establishing a framework for the setting of ecodesign requirements for energyusing products, as well as council directive 92 42 eec and directives 9657ec and 200055ec, as regards the implementing powers conferred on the. Council directive 9368 eec of 22 july 1993 the council of the european communities, has adopted this directive. Council directive 9251eec of 18 june 1992 on a second. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Directive 92 83 eec hereafter referred to as the directive defining inter alia, excise categories, the scope for reduced rates and exemptions while directive 92 84 eec fixes minimum rates for alcohol. 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 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 9242eec covers the efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Conformity assessment services for the free movement of construction products. Read online b council directive 93 42 eec of 14 june 1993 concerning. Directive 92104eec mineralextracting industries safety. Council directive 9229eec of 31 march 1992 on the minimum. Directive 9229eec medical treatment on board vessels. Classification criteria definitions for the classification.
The new machinery directive has been applicable since 29th december 2009. Member states shall assess the guides to good hygiene practice referred to in paragraphs 1 and 2 with a view to determining the extent. The habitats directive environment european commission. Environmental design for energyrelated products directive 2009125ec equipment for potentially explosive environments directive 201434eu explosives for civil use directive 201428eu gas appliances directive 2009142ec hotwater boilers directive 9242eec invitro diagnostics directive 9879ec. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. All books are in clear copy here, and all files are secure so dont worry about it. The revised machinery directive does not introduce radical changes compared with the.
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