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. Bs en 15986 is the standard for symbols for use in the. Bs en 15986 is the british standard that specifies the requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by annex i of directive 93 42 eec section 7. Compliance with the medical devices directive 9342eec st helens and knowsley teaching hospitals nhs trust confirms that the app is designed and manufactured to comply with the relevant essential requirements set out in the medical devices directive 9342eec. The content of this page deals only with the medical devices directive 93 42 eec.
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. Council directive 9338eec of 14 june 1993 coordinating. Medical device standards quality management systems. Download more information regarding the process for changes in the certification status. B council directive 9342eec of 14 june 1993 concerning.
Requirements for labelling of medical devices containing phthalates. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 93 42 eec last amended by directive 200747ec annex i, section 7. 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. Council directive 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. 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. Council directive 9343eec on the hygiene of foodstuffs. Classification criteria definitions for the classification rules. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. F2 labs can perform the emc and safety testing that is required by the medical device directive for. Council directive 9344eec of 14 june 1993 amending directive 89392eec on the approximation of the laws of the member states relating to machinerythe 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. This article shall apply without prejudice to council decision 8945eec of 21 december 1988 on dangers arising from the use of consumer products 6 and council directive 9259eec on general product safety 7. Council directive 9342eec of 14 june 1993 concerning. The eu medical device regulation mdr is far more complex than the medical devices directive 9342eec it replaces and presents new challenges for manufacturers.
Ce marking medical devices mdd sherpa product certification. Directive 9368eec amending directives 89392eec machinery atex directives. The primary purpose of the directive is to develop a single market in explosives through the harmonisation of product safety standards. Directive 9344eec amending directive 89392eec machinery. 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 9242eec covers the efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels. Application of the classification rules shall be governed by the intended purpose of the devices.
Medical devices directive 9342ec evaluation and testing. The eu medical device regulation mdr is far more complex than the medical devices directive 93 42 eec it replaces and presents new challenges for manufacturers. Conformity with the aforementioned directive is certified by the ce mark on the device. Kg develops and produces the highest quality medical products with the greatest. Council directive 9312eec of 23 march 1993 relating to. Overview a medical device is defined in directive 93 42 eec as.
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. Nol 1692 official journalofthe europeancommunities. Ec declaration of conformity directive 7323eec, 9368eec document code 00109155. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Amalgam dental amalgam a report with reference to the medical devices directive 9342eec, ad hoc working group mandated by dg. New european regulation for medical devices to replace 9342. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. Council directive 9338eec of 14 june 1993 coordinating the. Information forwarded pursuant to article 6 of this directive, in whatever form, is covered by professional secrecy.
Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. Council directive 93 42 eec of 14 june 1993 concerning medical devices. We abb industry oy hiomotie, finoo381 helsinki, finland declare under our. Use the following index to navigate into the different sections of the directive. Directive of medical devices 2001 guidelines for classification of medical devices guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec. Council directive 9344eec of 14 june 1993 amending directive 89392eec on the approximation of the laws of the member states relating to machinerythe 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. This product fulfils the requirements of the european council directive 93 42 eec on medical devices. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. Download council directive 9342eec on medical devices mdd. This article shall apply without prejudice to council decision 8945 eec of 21 december 1988 on dangers arising from the use of consumer products 6 and council directive 9259 eec on general product safety 7. Medical devices directive 93 42 eec pdf download 10yi83. This document is available in either paper or pdf format. 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. 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 description.
Classification criteria definitions for the classification. According to the european medical device directive 93 42 eec, a medical device is. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Apply the articles of the european directive 9342eec and follow the acceptable paths to enable the use of a declaration of conformity and the ce mark. Council directive 9343eec of 14 june 1993 on the hygiene. The content of this page deals only with the medical devices directive 9342eec. 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. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. If the device is intended to be used in combination with another device, the. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Council directive 9343eec of 14 june 1993 on the hygiene of.
Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. Directive of medical devices 2001 guidelines for classification of medical devices guidelines relating to the demarcation between directives 90385 eec, 93 42 eec and 6565 eec. Apply risk evaluation and risk control principles to their devices which affect decision making on the acceptability of risks in bringing a device to market. 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. This product fulfils the requirements of the european council directive 9342eec on medical devices. Overview eu directives and guidelines concerning the eu dental market 2082007 subject. Please note that this website will be undergoing some updates this week. Eu mdr 2017745 transition to the european medical device. Questions relating to the implementation of directive 200747 ec 1. The medical device directive is intended to harmonise the laws relating to medical devices. Overview eu directives and guidelines 2082007 concerning. Council directive 9399eec of 29 october 1993 on the subject. 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.
Overview a medical device is defined in directive 9342eec as. Bs en 15986 is the british standard that specifies the requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by annex i of directive 9342eec section 7. 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. 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 description. Council directive 9399eec of 29 october 1993 on the.
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. Annex v of the directive 9342eec european medical devices directive, development and manufacturing of medical devices. The device may only be operated via the usb port of a computer which was designed according to the. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 9342eec last amended by directive 200747ec annex i, section 7. Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. The ce marking directive 9368eec ce marking association. According to the european medical device directive 9342eec, a medical device is. Guidelines relating to demarcation between directive 90385.
Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. The revision of the medical devices directive 9342eec. New european regulation for medical devices to replace. 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.
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. Apply the articles of the european directive 93 42 eec and follow the acceptable paths to enable the use of a declaration of conformity and the ce mark. Medical devices internal market, industry, entrepreneurship. Understanding the european directive 9342eec for medical. Directive 93 68 eec amending directives 89392 eec machinery atex directives. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Directive 9342eec mdd medical devices directive with. The medical device directive council directive 9342eec 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. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device.
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. Medical devices directive 93 42 eec try it for free on. Consequently, users may experience instabilities and limited functionality. 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 93eec of 5 april 1993 on unfair terms. Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Directives and regulations two and threewheel vehicles. 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. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Commission directive 200627ec of 3 march 2006 amending for the purposes of adapting to technical progress council directives 93 14 eec on the braking of two or threewheel motor vehicles and 93 34 eec on statutory markings for two or threewheel motor vehicles, directives of the european parliament and of the council 951ec on the maximum.
71 28 77 1144 1411 55 1269 1176 667 1602 918 199 1277 712 1609 1144 503 691 1451 1163 431 1109 1419 401 301 811 1105 790 753 155 1479 755 1271 440 1484 1217 691 579 14