The medical devices directive 9342eec 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. 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. Classification criteria definitions for the classification. Please find the latest consolidated ivdd 9879ec below.
Mds 7003 medical devices incorporating derivates of human blood, according to directive 200070ec, amended by directive 2001104ec mds 7004 medical devices referencing the directive 2006 42 ec on machinery creation date. At the end of the course, you will be able to implement the requirements of the directive and to audit organizations against it. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. 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. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. 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. Medical device directive 9342eec latest amended by directive 200747ec terumo product related risk management documents en 15986.
Published in the official journal of the european union ojeu in march 2014, the red is in a 2 year transition period and comes into force on th june 2016. 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 200070ec of the european parliament and of the council of 16 november 2000. European medical device directive essential requirements. Classification criteria definitions for the classification rules.
Article 1 of the medical devices directive 9342eec nrlcontaining medical devices i. 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. Europa enterprise guidelines on the implications of. The european medical device directive or 9342eec regulates which medical devices may be sold in the european market, while 21 cfr 820 is an fda quality systems regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company organization in order to ensure that their manufacturing processes and the resultant products. Bsi training european medical devices directive requirements. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec oj l 189, 20. Eu medical device directive 9342eec labelling requirements. The content of this page deals only with the medical devices directive 93 42 eec. Annex ix 9342eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. 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. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. The ivd directive was amended and corrected over time. Medical devices directive 93 42 ec evaluation and testing.
Medinfo council directive international expert information. List european harmonized standards for the medical devices. On friday 27 april 2012, the european commission published updated lists of the european harmonized standards that pertain to the medical devices directive 9342ec, in vitro diagnostics directive 9879ec, and the active implantable medical devices directive 90385eec. 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. 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 93 42 eec of 14 june 1993 concerning medical devices. This document is meant purely as a documentation tool and. New european regulation for medical devices to replace 9342. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. The essential requirements of the medical device directive 9342eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. Council directive 9342eec of 14 june 1993 concerning. The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. The medical device directive is intended to harmonise the laws relating to medical devices.
Understanding the european directive 9342eec for medical. This document is available in either paper or pdf format. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Understanding the medical devices directive 9342eec 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. The minister for health, in exercise of the powers conferred on him by section 3 of the european communities act, 1972 no. Medical devices complying with the radio equipment directive. Because of the many types of devices covered by the mdd, the specific requirements depend on. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. 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. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. There is something for everyone to take away in this webinar and the content is vitally important to understand for full european compliance when placing medical devices on the market. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.
Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 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. 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. Lists of harmonised standards list of harmonised standards under directive 9342eec for medical devices list of harmonised standards under directive 9879ec for in vitro diagnostic medical devices. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. Council directive 9342eec on medical devices mdd 1993. Essential requirements annex i, 9342eec as compliance. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. The revision of the medical devices directive 9342eec. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.
Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Medical devices directive mdd 9342eec explained in the medical device directive m. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. New european regulation for medical devices to replace 93. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Directive 9879ec of the european parliament and of the council of 27 october 1998. Directives 90385eec and 9342eec medical devices clinical. Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of iso 485. 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. In order to place a medical device onto the european. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories.
Medical devices directive 9342ec evaluation and testing. Council directive 9342eec on medical devices diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for injuries or handicaps investigation, replacement or modification of the anatomy or of a physiological process conception control. Europa enterprise guidelines on the implications of the. Council directive 9342eec of 14 june 1993 concerning medical devices. The directive is written in the new legislative framework and will bring significant changes for medical device manufacturers. Details of the mdd 9342eec directive essential requirements. Medical devices internal market, industry, entrepreneurship. Compliance with medical device directive 9842eec mdd. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in article 1 2 a, as specified by the manufacturer. Medical devices directive 93 42 eec try it for free on.
This represents the minimum standard a manufacturer is expected to. Annex ix 93 42 eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies. 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. Delivered inhouse, this 1day practical workshop provides an awareness of the european directive 9342eec concerning medical devices. Mds 7003 medical devices incorporating derivates of human blood, according to directive 200070ec, amended by directive 2001104ec mds 7004 medical devices referencing the directive 200642ec on machinery creation date. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Overview a medical device is defined in directive 93 42 eec as. Title compliance with medical device directive 98 42 eec mdd description the course is designed to give you an understanding of the requirements of the medical device directive 93 42 eec as amended in 200747ec. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. 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. Revision of mdd 93 42 eec, aimd 90385 eec and bpd 988ec published. Rule 10 active devices intended for diagnosis are in class iia.
Council directive 93 42 eec on medical devices diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for injuries or handicaps investigation, replacement or modification of the anatomy or of a physiological process conception control. The medical devices directive as with all products which meet the definition of a medical device as detailed in article 1 of the medical devices directive 9342eec nrlcontaining medical devices i. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. 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. Ubersetzungen fur council directive 93 42 eec of 14 june 1993 concerning medical devices im englischdeutschworterbuch, mit echten sprachaufnahmen, illustrationen, beugungsformen. Conformity with medical device directive 9342eec is mandatory all devices. 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. Medical device directive 9342eec cemarking qnet, llc. 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. Rule 2 all noninvasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in class iia.
F2 labs can perform the emc and safety testing that is required by the medical device directive for. Title compliance with medical device directive 9842eec mdd description the course is designed to give you an understanding of the requirements of the medical device directive 9342eec as amended in 200747ec. Details of the mdd 93 42 eec directive essential requirements. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. B council directive 9342eec of 14 june 1993 concerning. Council directive 93 42 eec of 14 june 1993 concerning. These sections are reproduced below for your information or. Manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. Download council directive 9342eec on medical devices mdd. 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. Personnel responsible for quality systems for medical device manufacturers will benefit from this.
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