List of medical devices which are labelled for dehp, as of. Recently, directive 200747ec amended the aimdd and mdd directives, aligning the legislative elements governing both directives. The ivd directive was amended and corrected over time. Directive 200747ec of the european parliament and of the council of. Compliance with the revised directive became mandatory on 21 march 2010. Council of the european union directive 200747ec, technical revision to aimd and mdd.
Directive 2007 47 ec 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 988 ec concerning the placing of biocidal. M5 mdd archives medical device academy medical device. Comprehensive guide on class i isim medical devices ce marking mark. A guide to european medical device trials and bs en iso 14155. Standalone software as an active medical device springerlink. Interactive web page allows for inpage navigation from section to section. Article 4 free movement, devices intended for special purposes.
Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a. Free movement, devices intended for special purposes. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending the council directive 90385eec on the approximation of. Or download the pdf of the directive or of the official journal for free this website uses cookies to ensure you get the best experience on our website. Medical device directive, how to identify non compliance areas, contents of the. Contents of technical documentation for mdd 9342eec and. Directive 2001104 ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. According to directive 200747ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means. Directive 9342eec covering medical devices modified by the directive 200747ce ivdd. Council directive 9342eec 3 requires the commission to submit a report to the council, no later than five years from the date of. M5 directive 200747ec of the european parliament and of the council of l 247 21 21. This webinar is further intended to provide guidance on the regulatory requirements set out in the mdd, which helps ensure that medical devices are safe and effective for their intended use. Changes to the medical device legislation in europe the impact of directive 200747 ec slideshare uses cookies to improve functionality and performance, and to.
Application to devices in class iia 47 annex vii ec declaration of conformity 48 1. Directive 200747ec1 amends the earlier medical device and active. Mdd 9342eec medical device directive, amended by the 200747ec, requires clinical data and an evaluation of that data to ensure the safety of the medical device. Obtaining and maintaining eu compliance under the medical device directive duration. Or download the pdf of the directive or of the official journal for free this website uses cookies to. Full text of the european medical devices directive 9342eec including amendments by 200747ec. 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. Medical device directive mdd 9342eec as modified by 2007 47 ec. Standards, legislation and other related documents medcert. A medical device that is placed on the market with an integral. Eu medical device regulations comprehensive compliance training course. Pdf clinical evaluations clinical investigations under the amended.
Please find the latest consolidated ivdd 9879ec below. There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 9342eec as modified by 200747ec. Eu medical devices directive mdd 9342eec and 200747ec. Directive 200746ec of the european parliament and of the council of 5 september 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices.
The clinical evaluation task force, a subgroup of the mdeg, proposed the changes found in directive 2007 47 ec that led to the amendments of mdd 9342eec. Article 4 free movement, devices intended for special purposes 9 article 5 reference to standards 10. The council of the european communities, having regard to the treaty establishing the european economic community, and in. The new regulation is four times longer, and contains five more annexes than its predecessor, the medical device directive mdd. 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 products on the market text with eea relevance. Full text of the european medical devices directive 9342eec including amendments by 2007 47 ec.
This document is not intended to provide every possible. Note that some of the text from this meddev document has been incorporated into directive 200747ec. Eu medical devices directive m5 amendment 93 42 eec regulatory update bsi b. Eu medical devices directive mdd 9342eec and 2007 47 ec. According to directive 2007 47 ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means. Szutest is also accredited for iso 485 certification by turkak and ias.
European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Guide on class i isim mdd medical devices ce marking. There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 9342eec as modified by 2007 47 ec. Scribd is the worlds largest social reading and publishing site. Understanding the medical devices directive 9342 eec 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. With the release of the latest european medical device directive mdd. Medical device directive mdd 9342eec as modified by 200747ec. The mdeg is composed of representatives from various organizations in europe and each member states competent authority. Meddev guidance list download medical device regulation. Directive 2007 47 ec 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. The major areas of change implemented under mdd 2007 47 ec are as follows. Active implantable medical device directive aimdd including amendments and corrections, the latest being directive 200747ec, published as a consolidated text at. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 9342eec last amended by directive 2007 47 ec annex i, section 7. 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.
Manufacturers products meeting harmonised standards have a presumption of conformity to the directive. Ce marking in medical devices, 9342at, 200747ec, ce certification, how to. Eu medical device directive eu mdd governing medical. Statement as to whether the product is listed in annex ii list a or b of directive 9879ec, or whether it is intended for selftesting coding by means of umdnsgmdn if available 4. Article 4 free movement, devices intended for special purposes 9. Dec 09, 2008 changes to the medical device legislation in europe the impact of directive 200747 ec slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Article 4 free movement 6 article 5 reference to standards 6. Eea, within the european free trade region and in some countries that have bilateral treaties with the eea, such as egypt. As regards the transitional regime of directive 200747ec see the.
Medical device usability david adams global head, active medical devices add logo on slide 4 here. The amended standard will be published by cen as soon as possible. Certificate of conformity we confirm that the technical documentation for the below mentioned product medical devices of the class i according to the council directive 9342eec as amended 200747ec. Directive 9879ec covering in vitro diagnostic medical devices some amending medical directives human tissue, breast implants, but also other directive exists. This webinar is intended to help you get familiar with the european union eu medical device directive mdd governing medical devices for ce marking. European unions ec directive 9879ec on in vitro diagnostic medical devices ivds. Directive 200747ec guidance document for mdd 9342eec. Mdd 9342eec medical device directive, amended by the 2007 47 ec, requires clinical data and an evaluation of that data to ensure the safety of the medical device.
B council directive 9342eec of 14 june 1993 concerning. Ce marking in medical devices, 9342at, 200747ec szutest. This standard still needs to be amended to take into account the requirements introduced by directive 2007 47 ec. Directive 2007 47 ec 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. Products conforming with the md directive must have a ce mark applied. Medical device directive 9342eec, active implantable medical devices directive 90385eec and biocidal products directive 988ec.
European medical device directive essential requirements. M4 regulation ec no 18822003 of the european parliament and of the l 284 1 31. Eu medical device directive, regulations, mdd, ce marking. Eec 200747ec council directive 200747ec 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. Declaration of conformity in the case of initial certifications in the form of a draft. M5 directive 200747ec of the european parliament and of the council text with eea relevance of 5 september 2007 l 247 21 21. Manufacturers are advised to check whether all relevant essential requirements of. For the purposes of this directive devices other than those referred to in the previous. Usability is very important and has become a vital part of a medical device usability activities should be conducted throughout all phases of the development process, usability should be part of the overall risk management process the regulators are increasing and enhancing the requirements for usability. Efta european free trade area en european standard. M5 directive 2007 47 ec of the european parliament and of the council of 5 september 2007 l 247 21 21. Medical device directive mdd including amendments, the latest being directive 200747ec.
Szutest, a member of team nb providing ce marking service, is the notified body with the identification number of 2195 notified for medical devices by the turkish ministry of health and the european commission. Ecdeclaration of conformity directive 9342eec products in mdd class iia it is hereby declared that the products listed below comply with the provisions of the ec council directive 9342eec of june 14th 1993, annex v, concerning medical devices mdd, as amended by ec council directive 200747ec, under the supervision of. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Most recently, in may 2007, the global harmonization task force ghtf published a guidance on clinical evaluation sg5n2r8.
Statement as to whether the product is listed in annex ii list a or b of directive 9879 ec, or whether it is intended for selftesting coding by means of umdnsgmdn if available 4. Council directive 9342eec of 14 june 1993 concerning medical devices. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020. Directive 200747ec amends directive 90385eec on active. M4 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. Specifically, there were four in december, 2009 and one in june, 2010. Medical devices directive 9342eec pdf download 10yi83. The european commission has issued an interpretative document dated 5 june 2009 of directive 2007 47 ec which amends the medical devices directive mdd 9342eec and the active implantable medical devices directive aimdd 90385eec. 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.
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. European medical devices directive 9342eec including amendments by 200747ec. The medical device directive council directive 9342eec of 14 june 1993. European medical device directive essential requirements checklist. Medical device directive 9342eec, active implantable medical devices directive 90385eec and biocidal products directive 988 ec. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical. Is required for all devices regardless of classification, i. List of medical devices which are labelled for dehp, as of 21. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Medical device standards iec 62304 mdd 200747ec software process. Clinical data is collected or generated from the clinical use of the device and observing the performance of this device and its safety.
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