Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. This standard still needs to be amended to take into account the requirements introduced by directive 2007 47 ec. 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. Most recently, in may 2007, the global harmonization task force ghtf published a guidance on clinical evaluation sg5n2r8. Directive 9879ec covering in vitro diagnostic medical devices some amending medical directives human tissue, breast implants, but also other directive exists.
European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Please find the latest consolidated ivdd 9879ec below. Directive 200747ec guidance document for mdd 9342eec. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the. 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. M5 directive 2007 47 ec of the european parliament and of the council of 5 september 2007 l 247 21 21. Declaration of conformity in the case of initial certifications in the form of a draft. Eu medical device directive, regulations, mdd, ce marking. 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. 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. Article 4 free movement, devices intended for special purposes 9 article 5 reference to standards 10. The clinical evaluation task force, a subgroup of the mdeg, proposed the changes found in directive 200747ec that led to the amendments of mdd 9342eec. The medical device directive council directive 9342eec of 14 june 1993. According to directive 2007 47 ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means.
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. Contents of technical documentation for mdd 9342eec and. 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. List of medical devices which are labelled for dehp, as of 21. Jan 01, 2010 the mdeg is composed of representatives from various organizations in europe and each member states competent authority. Is required for all devices regardless of classification, i. Products conforming with the md directive must have a ce mark applied. Full text of the european medical devices directive 9342eec including amendments by 2007 47 ec.
Or download the pdf of the directive or of the official journal for free this website uses cookies to. Interactive web page allows for inpage navigation from section to section. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical. Article 4 free movement 6 article 5 reference to standards 6. Specifically, there were four in december, 2009 and one in june, 2010. European medical device directive essential requirements checklist. 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. Council directive 9342eec 3 requires the commission to submit a report to the council, no later than five years from the date of. Efta european free trade area en european standard. European unions ec directive 9879ec on in vitro diagnostic medical devices ivds.
Medical device directive, how to identify non compliance areas, contents of the. Eu medical devices directive m5 amendment 93 42 eec regulatory update bsi b. Scribd is the worlds largest social reading and publishing site. Medical device directive mdd 9342eec as modified by 200747ec.
Clinical data is collected or generated from the clinical use of the device and observing the performance of this device and its safety. The council of the european communities, having regard to the treaty establishing the european economic community, and in. Eu medical devices directive mdd 9342eec and 2007 47 ec. Medical device directive mdd including amendments, the latest being directive 200747ec. 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. Medical devices directive 9342eec pdf download 10yi83. M4 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. According to directive 200747ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means. Medical device usability david adams global head, active medical devices add logo on slide 4 here. 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. There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 9342eec as modified by 200747ec. Ce marking in medical devices, 9342at, 200747ec, ce certification, how to. 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.
Standalone software as an active medical device springerlink. Free movement, devices intended for special purposes. The new regulation is four times longer, and contains five more annexes than its predecessor, the medical device directive mdd. 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.
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. Eu medical devices directive mdd 9342eec and 200747ec. For the purposes of this directive devices other than those referred to in the previous. 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. Eea, within the european free trade region and in some countries that have bilateral treaties with the eea, such as egypt. Then there were two more meddevs released in december, 2010 related to clinical study requirements in europe. Medical device directive 9342eec, active implantable medical devices directive 90385eec and biocidal products directive 988 ec.
As regards the transitional regime of directive 200747ec see the. Article 4 free movement, devices intended for special purposes 9. Active implantable medical device directive aimdd including amendments and corrections, the latest being directive 200747ec, published as a consolidated text at. M5 directive 200747ec of the european parliament and of the council text with eea relevance of 5 september 2007 l 247 21 21. B council directive 9342eec of 14 june 1993 concerning.
M4 regulation ec no 18822003 of the european parliament and of the l 284 1 31. Guide on class i isim mdd medical devices ce marking. Meddev guidance list download medical device regulation. The amended standard will be published by cen as soon as possible. List of medical devices which are labelled for dehp, as of. 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. Recently, directive 200747ec amended the aimdd and mdd directives, aligning the legislative elements governing both directives. 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. This document is not intended to provide every 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 200747ec amends directive 90385eec on active. A medical device that is placed on the market with an integral.
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. Eu medical device regulations comprehensive compliance training course. 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. 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. Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a. European medical device directive essential requirements. 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. M5 mdd archives medical device academy medical device. Medical device directive mdd 9342eec as modified by 2007 47 ec. Directive 200747ec1 amends the earlier medical device and active. The major areas of change implemented under mdd 2007 47 ec are as follows.
Ce marking in medical devices, 9342at, 200747ec szutest. Standards, legislation and other related documents medcert. Application to devices in class iia 47 annex vii ec declaration of conformity 48 1. Note that some of the text from this meddev document has been incorporated into directive 200747ec. Compliance with the revised directive became mandatory on 21 march 2010. With the release of the latest european medical device directive mdd. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. Medical device standards iec 62304 mdd 200747ec software process. 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. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. The mdeg is composed of representatives from various organizations in europe and each member states competent authority. 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. Full text of the european medical devices directive 9342eec including amendments by 200747ec.
The ivd directive was amended and corrected over time. Changes to the medical device legislation in europe the impact of directive 200747 ec slideshare uses cookies to improve functionality and performance, and to. Council directive 6565eec of 26 january 1965 on the approximation of. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending the council directive 90385eec on the approximation of. Manufacturers are advised to check whether all relevant essential requirements of. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Directive 200747ec of the european parliament and of the council of. A guide to european medical device trials and bs en iso 14155. Council of the european union directive 200747ec, technical revision to aimd and mdd. This webinar is intended to help you get familiar with the european union eu medical device directive mdd governing medical devices for ce marking. Manufacturers products meeting harmonised standards have a presumption of conformity to the directive. Eu medical device directive eu mdd governing medical. Obtaining and maintaining eu compliance under the medical device directive duration. 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 products on the market text with eea relevance.
Pdf clinical evaluations clinical investigations under the amended. Directive 9342eec covering medical devices modified by the directive 200747ce ivdd. Medical device directive 9342eec, active implantable medical devices directive 90385eec and biocidal products directive 988ec. 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. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020. Szutest is also accredited for iso 485 certification by turkak and ias. European medical devices directive 9342eec including amendments by 200747ec. 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. 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. Council directive 9342eec of 14 june 1993 concerning medical devices. Directive 2001104 ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. Comprehensive guide on class i isim medical devices ce marking mark. Article 4 free movement, devices intended for special purposes. M5 directive 200747ec of the european parliament and of the council of l 247 21 21.
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