Unfair terms in consumer contracts regulations 1999 statutory instrument 1999 no 2083. The ivd directive was amended and corrected over time. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Decisions with regard to classification, derogation clause. Medical device directive mdd 93 42 eec as modified by 200747ec.
Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 93 43 eec on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. Directive as last amended by directive 200145ec of the european parliament and of the council oj l 195, 19. B council directive 9343eec of 14 june 1993 on the hygiene. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts 1993 o j l 095, 2934. 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. B council directive 93 43 eec of 14 june 1993 on the hygiene of foodstuffs oj l 175, 19. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Unfair terms in consumer contracts directive 1993 wikipedia. Apr 21, 2016 the court of justice delivered today its judgment in case c. For the purposes of the directive the term food hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs.
Particular requirements for the safety and essential performance of anaesthetic systemsi. Directive council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. 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 oj l 169, 12. In the years folowing entry into force of the directive, although efsa has not. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Directive 93cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts. B council directive 9343eec of 14 june 1993 on the.
The essential requirements of the medical device directive 93 42 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. It applies without prejudice to more specific community food hygiene regulations. 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 93eec of 5 april 1993 on unfair terms in consumer contracts 1993 o j l 095, 2934. Council directive 93 96 eec of 29 october 1993 on the right of residence for students extends the right of residence to students and their family members. 2 council directive 9088 eec of 22 february 1990 amending directive 87102 eec for the. Official journal no page date m1 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. Article 4 of directives 90364eec and 90365eec and article 5 of directive 9396eec lay down the obligation of the european commission to draw up a. Whereas council directive 90385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards.
Council directive 93eec of 5 april 1993 on unfair terms. Please find the latest consolidated ivdd 9879ec below. The essential requirements of the medical device directive 9342eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Article 4 of directives 90364 eec and 90365 eec and article 5 of directive 93 96 eec lay down the obligation of the european commission to draw up a report on.
Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. Eu medical device directive 9342eec labelling requirements. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om. Directive 93 cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories.
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 9342eec of 14 june 1993 concerning. Medical devices directive 93 42 eec pdf download, private parts howard stern epub download ae94280627 om. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. In view of the breadth of the scope of the directive and the variety of products covered, it. B council directive 9342eec of 14 june 1993 concerning. Whereas, in decision 90683 eec of december 1990 concerning. 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. B council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs oj l 175, 19.
Di rective as last amended by directive 9368eec oj no l 220, 30. Unfair contract terms directive, council directive 93eec of 5 april 1993 council directive 93eec 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. Council directive 9343eec on the hygiene of foodstuffs. 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. In directive 93eec, the following article is inserted.
Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. The court of justice delivered today its judgment in case c. Introduction1 the objective of this document is to clarify certain matters and procedures referred to in 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. The ce marking directive 9368eec ce marking association. Article 71 of council directive 93 precludes national legislation. Free movement, devices intended for special purposes. If the appliance is at the same time a medical device within the meaning of directive 9342eec 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. Council directive 9338eec of 14 june 1993 coordinating the. These sections are reproduced below for your information or. 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. Council directive 9338eec of 14 june 1993 coordinating. Article 1 amendment to directive 93eec directive eu. 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. Member states shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented.
S bright, winning the battle against unfair contract terms 2000 20 l studies 331, 332. This directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with the rules. Product placement on the market cannot be prevented by any eu country if a device caries a ce mark which is a confirmation that this device meets the basic requirements according to annex 3. Commission communication in the framework of the implementation of the council directive 93 42eec concer ning medical devices publication of titles and references of har monised standards under union har monisation legislation text with eea relevance 2017c 38903 eso 1. Pressure equipment directive content pressure equipment directive.
The directive 93 68 eec details the specific changes to each individual directive in articles 2 to. Adoption process of directive 93 98 eec 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. Directive 93 eec, directive 986ec of the european parliament and of the council, directive 200529ec of t he european parliament and of the. The directive 9368eec details the specific changes to each individual directive in articles 2 to. The revision of the medical devices directive 9342eec. Council directive 9396eec of 29 october 1993 on the right of residence for students extends the right of residence to students and their family members.
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 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. Council directive 9342eec of 14 june 1993 concerning medical devices. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. This free of charge application was designed to help manufacturers, consultants, notified. 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. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100 a thereof. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Now that new substantial amendments are being made to directive 98 37ec, it is desirable, in order to clarify matters, that that directive. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 57 2 thereof, having regard to the proposal from the commission 1, in cooperation with the european.
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