Directive 93 42 eec pdf

Directive of active implantable medical devices 9879ec. The content of this page deals only with the medical devices directive 93 42 eec. Council directive 93 42 eec 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 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Council directive 9368eec of 22 july 1993 amending.

F1 substituted by 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 active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing. Classification criteria definitions for the classification rules. Directive 9342eec s on medical devices, annex v restricted to the aspects of manufacture concerned withsecuring gs. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Les directives europeennes relatives aux dispositifs medicaux. 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. New european regulation for medical devices to replace 9342. 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. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. 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. Directive 200747ec guidance document for mdd 9342eec.

F2 inserted by 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 active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of. Revision of mdd 93 42 eec, aimd 90385 eec and bpd 988ec published. Medical device means any instrument, apparatus, appliance, software. European medical device directive essential requirements. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Commission communication in the framework of the implementation of council directive 93 42 eec concerning medical devices text with eea relevance. Council directive 9343eec on the hygiene of foodstuffs. The medical devices directive 93 42 eec link to support material guides particularly useful to manufacturers are the meddev guidance documents which promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Commission communication in the framework of the implementation of the council directive 93 42 eec 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 reference and title of the standard. 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. Eu medical device directive 9342eec labelling requirements. Council directive 93 43 eec of 14 june 1993 on the hygiene of foodstuffs eu law. Ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives. 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.

Application of the classification rules shall be governed by the intended purpose of the devices. Because of the many types of devices covered by the mdd, the specific requirements depend on the. 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. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Directive 93 37 eec this guide has no legal value and does not necessarily represent the official position of the commission hosted on the public procurement portal. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Directive 9879ec of the european parliament and of the council of 27 october 1998. A medical device is defined in directive 9342eec as. Medical devices guidance document classification of. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.

Overview a medical device is defined in directive 93 42 eec as. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. Commission communication in the framework of the implementation of the council directive 93 42 eec 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. Council directive 9342eec of 14 june 1993 concerning medical devices. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Particular requirements for the safety of multifunction patient monitoring equipmentiec. Active implantable medical devices directive 90385eec try it for free on. 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. Directive 9342cee du conseil du 14 juin 1993 relative aux dispositifs medicaux.

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. Questions relating to the implementation of directive 200747 ec 1. Essential requirements annex i, 9342eec as compliance. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Regulation eu 2017745 of the european parliament and of. The ivd directive was amended and corrected over time.

Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to. Compliance of medical devices with the new requirements according to article 2 of directive 93 42 eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if. Having regard tothe treatyestablishing the european economic community, andin. If the device is intended to be used in combination with another device, the.

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. The medical device directive council directive 93 42 eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. Guidelines relating to the demarcation between directives 90385 eec, 93 42 eec and 6565 eec. The mdr, which replaces the medical devices directive 93 42 eec and active implantable medical devices directive 90385 eec, has a transition period of three years. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. This document is available in either paper or pdf format. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices directive 200070ec of the european parliament and of the council of 16 november. The directive 93 42 eec on medical devices mdd 93 42, is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. New european regulation for medical devices to replace 93. Any instrument, apparatus, appliance, material or other article, whether. 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. Council directive 9342eec on medical devices mdd 1993.

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 active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing of biocidal. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec text with eea relevance. Medical devices directive 9342eec pdf download 10yi83. 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. Medical devices directive 93 42 eec medical electrical equipment part 249. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om.

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 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Ce marking and european medical device directive 9342cee. Directive 9342cee relative aux dispositifs medicaux qualitiso. The social cost of the large number of accidents caused by the use of machinery can be reduced by. Following the latter directive, accessories are by definition medical devices, whilst following directive 93 42 eec, a. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to. The ce marking directive 9368eec ce marking association. Regulation eu 2016425 on personal protective equipment.

B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Medical devices directive 93 42 eec medical electrical equipment characteristics of digital xray imaging devices part. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be. Medical devices internal market, industry, entrepreneurship. The manufacturer should first decide if the product concerned is a medical device as defined in directive 93 42 eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. Medical device directive 9342eec cemarking qnet llc. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md. Essential requirements annex i, 93 42 eec as compliance. Objective the aim of this regulation is to ensure common standards for personal protective equipment ppe in all member states in terms of protection of health and the. Directive 93 42 eec 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. Le conseil des communautes europeennes, vu le traite. 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. B council directive 9342eec of 14 june 1993 concerning. This free of charge application was designed to help manufacturers, consultants, notified.

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. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. Council directive 9342eec of 14 june 1993 concerning. Please find the latest consolidated ivdd 9879ec below. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Medical devices directive 93 42 eec breathing system filters for anaesthetic and respiratory use part 2. Download council directive 9342eec on medical devices mdd. Directive 200070ec of the european parliament and of the council of 16 november 2000. Medical devices directive 93 42 ec evaluation and testing. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 93 42 eec and the active implantable medical devices directive aimdd 90385 eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. Ce marking and european medical device directive 93 42 cee. Council directive 93 68 eec of 22 july 1993 amending directives 87404 eec simple pressure vessels, 88378 eec safety of toys, 89106 eec construction products, 89336 eec electromagnetic compatibility, 89392 eec machinery, 89686 eec personal protective equipment, 90384 eec non.

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