The medical device regulation of the european union intensifies. Overview a medical device is defined in directive 93 42 eec as. 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. The content of this page deals only with the medical devices directive 93 42 eec. In the meantime, national registration requirements for devices placed on the market in accordance with the mdd and ivdd will apply until may 2020. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Medical devices directive 93 42 eec last official journal reference wednesday 25th of march 2020 description. Bsi training european medical devices directive requirements. Or download the pdf of the directive or of the official journal for free. The european parliament and council directive 9342eec has been implemented in order to unify marketing rules over each member state in the meaning of single common market.
The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. This document is available in either paper or pdf format. Download from the link below the mdr in the main european languages. 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. All books are in clear copy here, and all files are secure so dont worry about it. References 89 90 council directive 93 42 eec of 14 june 1993 concerning medical devices as last. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Sign in here to access free tools such as favourites and alerts, or to. Medical devices directive 93 42 ec evaluation and testing manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. 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. Bsis european medical devices directive requirements course is designed to provide a top level overview of the guidelines of the european medical device directives mdd 9342eec and comprehensive information on the mdd 200747 changes. Medical device directive 9342eec latest amended by directive 200747ec terumo product related risk management documents en 15986. This document is meant purely as a documentation tool and the.
If the device is intended for use in combination with other devices or equipment, the whole. New european regulation for medical devices to replace 9342. B council directive 9342eec of 14 june 1993 concerning. 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. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. 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. Directive of medical devices 2001 guidelines for classification of medical devices guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec. This webinar will provide valuable assistance and guidance to medical device companies that are preparing for ce mark and ensuring compliance to mdd 93 42 eec.
Medical device 9342eec certification if you want to enter european economic area with your product qualified as medical device, ce marking is the only way how to proceed. May 27, 2011 when medical device companies do business in europe, they are required to conform to the eus medical device directive, 93 42 eec. On friday 27 april 2012, the european commission published updated lists of the european harmonized standards that pertain to the medical devices directive 93 42 ec, in vitro diagnostics directive 9879ec, and the active implantable medical devices directive 90385 eec. This document is an excerpt from the eurlex website.
Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. 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. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Council directive 93 42 eec of 14 june 1993 concerning medical devices. 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.
The third directive is the in vitro diagnostics directive 9879ec. Council directive 9342eec of 14 june 1993 concerning medical devices. Read online list of bodies notified under directive. Both the medical device directive 93 42 eec and the active implantable medical devices directive 90385 eec have been modified by a new directive 200747ce. Medical devices directive 93 42 eec try it for free on. Council directive 9342eec of 14 june 1993 concerning. Iso 485 how to use it to get the medical device ce mark. Here you can download documents, technical product manuals and graphic files. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. 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. All levels of management for all departments and those who desire a better understanding or a refresh overview.
This free of charge application was designed to help manufacturers, consultants, notified. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385 eec oj l 189, 20. Directive 9879ec of the european parliament and of the council of 27 october 1998. Get your kindle here, or download a free kindle reading app. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Article information, pdf download for the medical device regulation of the european. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products.
Both the medical devices directive 93 42 eec and in vitro diagnostic medical device directive 9879ec require manufacturers or, their authorised representatives or others placing medical devices on the eea market, to provide certain information to the competent authorities in the eea member state where they have a registered place of. Download council directive 9342eec on medical devices mdd. One important way to comply is to use the applicable standards from the harmonised list for medical devices. List european harmonized standards for the medical devices.
Medical devices directive mdd 9342eec explained in the medical device directive m. Contents of technical documentation for mdd 9342eec. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Essential requirements annex i, 9342eec as compliance. 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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Interpretative document of the commissions services.
Medical devices directive 93 42 eec pdf download 10yi83. The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. These sections are reproduced below for your information or. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Revision of article 3 directive 93 42 eec and of directive 90385 eec 4 to ensure simplification in legislation, both directive 93 42 eec on medical devices and directive 90385 eec on active implantable medical devices have been amended by directive 200747ec which added the following paragraph to their respective article 3. The medical device directive,published by the european commission from the. Medinfo medinfo council directive 9342eec on medical devices. 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. Oct 12, 2017 three different directives are applicable to different types of medical devices in europe. This section shows you chapterspecific coding guidelines to increase your understanding and correct usage of the target icd10cm volume 1 code. Download declaration in word or pdf format, with your logo. European medical device directive essential requirements.
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. The concept of compatibility between medical devices is dealt with in annex i of directive 93 42 eec relating to the essential requirements applicable to medical devices, under the following points. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Eu medical device directive 9342eec labelling requirements. Directive 93 42 ec on medical devices mdd and directive 9879ec on in vitro diagnostic medical devices ivdd will be repealed once the mdr and ivdr are fully applicable. Right click on the link below to download to your computer select save target as. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission.
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