B council directive 9342eec of 14 june 1993 concerning. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. Council directive 93 42eec concerning medical devices, as amended. Decisions with regard to classification, derogation clause.
Application of the classification rules shall be governed by the intended purpose of the devices. Directive 9411ec is a legal act of the european union concerning labelling apply to the materials used in footwear, including parts sold separately please login or subscribe to see the content. It should be read in conjunction with vigilance guidance for ivds and advice for notified bodies on self tests available on the mhras website. Directive 201193eu of the european parliament and of the council of december 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing council framework decision 200468jha, eurocrim, database on european criminal law. 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. 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. It is very common when searching for guidance on ce marking to come across the ce marking directive 93 68eec and it often causes confusion, as its purpose is not overly clear. Eu medical devices directive m5 amendment 93 42 eec.
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. The ce marking directive 9368eec ce marking association. The council has abandoned the protocol of numbering the directives in the title and the new directive, council directive 2006112ec, is commonly referred to as the vat prime directive is this a subtle nod to star trek by taxation geeks. The directive coordinates national laws on consolidated i. Directive 9368eec amending directives 89392eec machinery atex directives. Celab can accomplish all the required tests in order to affix the ce marking related to emc, lvd, red. All gloves of intermediate and complex design must now. Guidance on the interpretation and application of council directive. Council directive 93eec of 5 april 1993 on unfair terms eurlex.
Report from the commission to the european parliament and the council assessing the implementation of the measures referred to in article 25 of directive 201193eu of december 2011 on combating the sexual abuse and sexual exploitation of children and child pornography. The new directive will likely propose new minimum tax levels for most forms of energy not covered by europes. 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. Directive 93103ec work on board fishing vessels safety. Council directive 93104ec of 23 november 1993 concerning. Directive 9316cee du conseil, du 5 avril 1993, visant a. Directive 89391eec osh framework directive safety and.
Our pdf merger allows you to quickly combine multiple pdf files into one single pdf document, in just a few clicks. 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. Ce marking assistant, your declarations of conformity online. Directive 200054ec biological agents at work safety. Directive ue relative aux dispositifs medicaux 9342cee. Understanding the machinery directive 2006 42ec the directive has been put in place because.
Council directive 93eec of 5 april 1993 on unfair terms in consumer. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100 a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. Bsi british standards presentation of eu medical devices directive m5 amendment 93 42 eec regulatory updates. Seminar regulatory update on medical devices in asia and eu. Conformity with medical device directive 93 42eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. At the moment, 28 european states are members of the eu 11 and 24 national languages are deemed working languages for legal and official purposes. 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 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Seventh council directive consolidated accounts of.
Presented at the hktdc hong kong international medical devices and supplies fair 2009. Protecting consumers from unfair terms in contracts. Council directive 93eec of 5 april 1993 on unfair terms. Guidelines instructions for use ifu for medical devices. In this process the medically desirable is brought into line with the medically possible, taking into account legal stipulations and the situation at the workplaces, and the result is guidelines which are oriented on daytoday procedures.
Directive 9342eec medical devices directive active implantable medical devices. Council directive 93104ec of 23 november 1993 concerning certain aspects of the organization of working time official journal l 307, 121993 p. Directive 93 68eec amending directives 89392eec machinery atex directives. Article 18 wrongly affixed ce marking 20 article 19 decision in respect of refusal or restriction 21 article 20 confidentiality 21 article 20a cooperation 22 article 21 repeal and amendment of directives 22 article 22 implementation, transitional provisions 24 article 23 this directive is addressed to the member states. Ce marking of premdd devices page 27 vdtuevdocument dn. Please find the latest consolidated ivdd 98 79ec below. The social cost of the large number of accidents caused by the use of machinery can be reduced by. June 2011 in vitro diagnostic medical device directive 98 79ec the ivd directive was published in 1998 by the european comission. Efilm 01 australian sponsor ibm australia limited level , ibm centre 601 pacific highway st leonards, nsw, 2065 australia abn 79 000 024 733 phone. The include directive is used to include a file during the translation phase.
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. Many translated example sentences containing european medical device directive frenchenglish dictionary and search engine for french translations. Directive 9879ec referred to in this document as the directive. Report from the commission on the implementation of council directive 93eec of 5 april 1993 on unfair terms in consumer contracts. List of eceutype examination certificates issued according to the directives 93 15eec and 201428eu the certificates issued after 01072010 are under cofrac acceditation. If the device is intended to be used in combination with another device, the. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. This directive tells the container to merge the content of other external files with the current jsp during the translation phase. Laveursdesinfecteurs dendoscopes automatiques series advantagemds. These regulations contain the legislative measures necessary for the implementation of three european community directives. The following is a thematic list of european union directives.
Ivass council directive 91674eec of 19 december1991. The ivd directive was amended and corrected over time. Treaty establishing the european economic community. Directive 93 103ec work on board fishing vessels of 23 november 1993 concerning the minimum safety and health requirements for work on board fishing vessels thirteenth individual directive within the meaning of article 16 1 of directive 89391eec. Qlogic 9000 series installation manual pdf download. You may code the include directives anywhere in your jsp page. Eu medical device directive 9342eec labelling requirements. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. Directive 200054ec biological agents at work of the european parliament and of the council of 18 september 2000 on the protection of workers from risks related to exposure to biological agents at work seventh individual directive within the meaning of article 161 of directive 89391eec. Directive 93cee du conseil, du 5 avril 1993, concernant.
Medical device directive mdd 93 42eec as modified by 200747ec. To support member states and the commission in determining the regulatory status of products, the commission may set up, in accordance with its internal rules, a group of. We note that measuring the scale of the phenomenon of child sexual abuse at eu level is a difficult task and that more. Directiva 93 cee a consiliului din 5 aprilie 1993 privind clauzele abuzive in contractele incheiate cu consumatorii. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Ce statement preface communications statements ce statement the ce symbol on the equipment indicates that this system complies with the emc electromagnetic compatibility directive of the european community 89336eec and to the low voltage safety directive 7323eec. In pla inenglish, if you place your company name on the device or label, you are the manufacturer. Essential requirements annex i, 93 42eec as compliance. These sections are reproduced below for your information or. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts. Directive 201192eu of the european parliament and of the council of.
Risk assessment and investment analysis merge the results in order to create. Disinfettanti e sterilizzanti a freddo per dispositivi medici invasivi e non invasivi. Council decision 93465eec of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives. The eu is a complex patchwork of national legal communities. Company profile atos, bedpan and instruments washer. Classification criteria definitions for the classification. European medical device directive essential requirements. In 1993 that directive was amended by directive 93 68eec, the socalled ce marking directive, solely in respect of the procedures for conformity assessment and conformity marking. Directive 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12. Or download the pdf of the directive or of the official journal for free. Designing a model of a digital ecosystem for healthcare and wellness using the business model canvas. This document is meant purely as a documentation tool and. Ineris is accredited by cofrac under number 50045 for certification of products and services scope of accreditation available on.
Whereas it is the responsibility of the member states to. Essentially it was introduced to amend existing directives for them to include the requirement to affix the ce mark. Use of work equipment directive 2009104ec concerns the minimum health and safety requirements for the use of work equipment by workers at work it places obligations on businesses and employers to take into account potential dangers to operators and other persons using or affected by machines and equipment. Directive 9411ec labelling applying to materials used in. The directive 93 68eec details the specific changes to each individual directive in articles 2 to.
Combating sexual abuse of children directive 201193eu. Directive 9342 cee du conseil, du 14 juin 1993, relative aux dispositifs medicaux journal officiel n l 169 du 12071993 p. Curia judgment of the court of justice in case c33217 of. Together with the fourth directive on the annual accounts of public limited liability companies, it belongs to the family of accounting directives formed by the community legal acts on company accounts. Ce mark cee directive 9342, concerning medical devices class 2a, 2b.
Council directive 93 68eec of 22 july 1993 oj l 220, 30. Directive 93 cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs. The following scheme, which deals with the different stages of reproduction, was agreed as an appropriate general scheme for the period of reproduction. The essential requirements of the medical device directive 9342 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. European directive 82711 cee, basic rules necessary for testing migration of the constituents of plastics materials and articles intended to come into contact with foodstuffs amended by european directive 938 cee and european directive 9748 cee. Objectivethe aim of this directive is to introduce measures to encourage improvements in the safety and health of workers at work. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Whereas council directive 76893eec of 23 november 1976 on the approximation of the laws of the member states relating to materials and articles intended to come into contact with foodstuffs 3, as last amended by the act of accession of spain and portugal 4, has been substantially amended on a number of occasions. Description council directive of 19 december 1991 on the annual accounts and consolidated accounts of insurance undertakings 91674eec. Standard contracts define the rights and duties of the parties concerned. European medical device directive french translation linguee. Directive 93cee du conseil, du 5 avril 1993, concernant les clauses abusives dans les contrats conclus avec les consommateurs.