This document is meant purely as a documentation tool and. 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 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. 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. We abb industry oy hiomotie , finoo381 helsinki, finland declare under our sole responsibility that the product. Commission directive 9386eec of 4 october 1993 adapting to technical progress. Ec declaration of conformity directive 7323eec, 9368eec document code 00109155. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts. Application of the classification rules shall be governed by the intended purpose of the devices. So, for example, while eu directive 200920ec which simply requires all vessels.
Council directive 9342eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385eec and 9342eec with respect to. Satellite and cable directive jump to navigation jump to. Our authorized representative in the european community is. Denotes a standard that is not harmonised to the directive. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. The user or integrator of merge healthcare products should keep the following issues in mind.
Ec declaration of conformity directive 7323eec, 9368eec. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the. Notified body the british standards institute bsi have been appointed to undertake activities pursuant to annex ii in respect of all devices. Approaches to the different levels of consumer protection in. B council directive 9622ec of 29 april 1996 concerning the. European parliament and council directive amending council directive 93 6 eec of 15 march 1993 on the capital adequacy of investment firms and credit instit11tions and council directive 93 22 eec of 10 may 1993 on investment services in the securities field presented by the commission pursuant to article 189 a 2 of the ectreaty. 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. References to directive 200439ec or to directive 9322eec shall be construed as references to directive 201465eu or to regulation eu no 6002014 and shall be read in accordance with the correlation table set out in annex iv of directive 201465eu. Council directive 9338eec of 14 june 1993 coordinating the. Commission directive 938ec amending council directive 82. 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. 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. Compliance of medical devices with the new requirements according to article 2 of directive 9342eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if.
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 9338eec of 14 june 1993 coordinating. 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. English council directive 9337eec of 14 june 1993 concerning the coordination of procedures for the award of public works contracts the council of the european communities, having regard to the treaty establishing the european economic community, and in particular. Equipment and protective systems intended for use in potentially explosi ve atmospheres keywords. Council directive 9312eec of 23 march 1993 relating to the. Pdf the purpose of this paper is to examine the implementation of the. B council directive 9343eec of 14 june 1993 on the. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. This directive was implemented into uk law by the public supply contracts regulations 1995. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100 a thereof. Directive 93 and its applicability to provisions in. Where a relevant hazard exists, devices which are also machinery within the meaning of article 2a of directive 200642ec of the european parliament and of the council of 17 may 2006 on machinery shall also meet the essential health and safety requirements set out in annex i to that directive to the extent to which those essential health and.
Directive 93 cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. Whereas, in decision 90683eec of december 1990 concerning the. 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. B council directive 9622ec of 29 april 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta. 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. Use the following index to navigate into the different sections of the directive. Detailed amendments were given, throughout from article 2 to article, to the 12 council directives listed in article 1. Annex 1 models were virtually unchanged by cad2, so there has been no change in the cad1 regime.
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. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular the second paragraph of article 7 thereof. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts 1993. 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. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Regulation eec no 230993 council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a european agency for the evaluation of medicinal products oj no l 214 of 24. Please find the latest consolidated ivdd 9879ec below.
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. Pdf the implementation of the unfair contract terms directive in. Councildirective93 eec 5 of1993 april on unfair termsin consumer contracts. This table reflects information which the member states have notified to the commission under article 8a of the directive. According to the guidelines stated in directive 9342eec of the european community, efilm is a class i medical device. Guidance on ec directive 93 36 eec public supply contracts, as amended by ec directive 9752ec virtually every contract let by government is subject to ec legislation. The ofts competition law functions are to be merged with the competition. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Understanding the medical devices directive 9342eec 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. Directive 949ec of the european parliament and the council. Council directive 9383eec of 27 september 1993 on the coordination of certain rules concerning and rights related to applicable to satellite broadcasting and cable retransmission is a european union directive which governs the application of and. 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. Commission and cen and cenelec, ratified on november 1984.
Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. State of procedure the proposal com 2002 443 final 20020222 cod was adopted by the. Directive 93 and its applicability to provisions in general terms and conditions. The consumer rights directive and its implications. Merge healthcare products with equipment from other vendors. Council directive 9343eec on the hygiene of foodstuffs. Interactive web page allows for inpage navigation from section to section. Directive 9342eec mdd medical devices directive with. B council directive 9342eec of 14 june 1993 concerning. Whereas article 1 of council directive 91250eec of 14 may 1991 on the legal protection of computer programs4 provides that member states are to protect. 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. Directive 20051ec of the european parliament and of the council of 9 march 2005 amending council directives 73239eec, 85611eec, 91675eec, 9249eec and 936eec and directives 9419ec, 9878ec, 200012ec, 2004ec, 200283ec and 200287ec in order to establish a new organisational structure for.
Council directive 93eec of 5 april 1993 on unfair terms in consumer. Council directive 9312eec of 23 march 1993 relating to the sulphur content of certain liquid fuels the council of the european communities, having regard to the treaty establishing the european economic community and in particular article 100 thereof. Directive 93eec in the united kingdom, taking particular account of judgments in. Council directive 9342eec of 14 june 1993 concerning medical devices. In view of the breadth of the scope of the directive and the variety of products covered, it.
Council directive 93 96 eec of 29 october 1993 on the right of residence for students. Whereas it is the responsibility of the member states to. The original 93 6 eec cad1 directive was amended by 9831 eec cad2, to incorporate banks own estimate of capital using valueatrisk techniques. Council directive 91157eec on batteries and accumulators containing certain dangerous. Member states must notify national measures going beyond the minimum harmonisation of the directive on unfair contract terms 93eec. A directive is a legal act of the european union which requires member states to achieve a. European procurement directives ec directive 9337 language. Anton van kimmenade merge emed spegelt 34 5674 cd nuenen netherlands. Successful interoperability of the workstation with other devices may require functions that are not specified within the scope of dicom. Directive 93cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof.
Full text of the european medical devices directive 9342eec including amendments by 200747ec. If the device is intended to be used in combination with another device, the. Commission directive 938ec amending council directive 82711eec laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs. 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. Council directive 9398eec of 29 october 1993 harmonizing the term of protection of and certain related rights. Council directive 93eec of 5 april 1993 on unfair terms. The court of justice delivered today its judgment in case c. 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. Due to the covid19 pandemic many businesses are closed for deliveries. Directive whereas the consumer mustreceive equal protection. 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. 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.
The ibm iconnect access software complies with the mdd council directive 9342eec of 14 june 1993. Directive 93 eec, 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. 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. Eec council directive 9368eec of 22 july 1993 ce logo. Directive 949ec of the european parliament and the council of 23 march 1994 author.
Guidance on the interpretation and application of council. Please ensure your ship to address is able to receive your purchase. In article 2 b of directive 93eec on unfair terms in consumer contracts, a consumer is defined as any natural person who, is acting for purposes which are. Anton van kimmenade merge efilm spegelt 34 5674 cd nuenen netherlands. In the years folowing entry into force of the directive, although efsa has not. The ivd directive was amended and corrected over time. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 57 2 thereof. The ce marking directive 9368eec ce marking association. 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. Medical devices directive mdd 9342eec with 200747ec consolidated version. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device.