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. Understanding the european directive 9342eec for medical. Bsi training european medical devices directive requirements. 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. 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. 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. 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. The content of this page deals only with the medical devices directive 93 42 eec. Eu medical device directive 9342eec labelling requirements. 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. 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. The minister for health, in exercise of the powers conferred on him by section 3 of the european communities act, 1972 no. Council directive 9342eec of 14 june 1993 concerning.
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. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Revision of mdd 93 42 eec, aimd 90385 eec and bpd 988ec published.
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. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. 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. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. 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. Rule 10 active devices intended for diagnosis are in class iia. 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. New european regulation for medical devices to replace 9342. 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. 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. In order to place a medical device onto the european. Europa enterprise guidelines on the implications of the.
Personnel responsible for quality systems for medical device manufacturers will benefit from this. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. The directive is written in the new legislative framework and will bring significant changes for medical device manufacturers. 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. 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. Medical devices directive mdd 9342eec explained in the medical device directive m. Medical devices complying with the radio equipment directive.
Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. 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. 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.
Annex ix 93 42 eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies. Medinfo council directive international expert information. Medical devices directive 9342eec european commission. Europa enterprise guidelines on the implications of. 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. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Because of the many types of devices covered by the mdd, the specific requirements depend on.
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. 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. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. Directive 200070ec of the european parliament and of the council of 16 november 2000. Medical device directive 9342eec cemarking qnet, llc. This document is available in either paper or pdf format. Council directive 9342eec on medical devices mdd 1993. Essential requirements annex i, 9342eec as compliance.
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. Article 1 of the medical devices directive 9342eec nrlcontaining medical devices i. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe.
Download council directive 9342eec on medical devices mdd. Medical devices directive 9342ec evaluation and testing. Council directive 9342eec of 14 june 1993 concerning medical devices. Classification criteria definitions for the classification. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system.
In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. 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. New european regulation for medical devices to replace 93. 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. B council directive 9342eec of 14 june 1993 concerning. 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. 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. Medical devices directive 93 42 ec evaluation and testing. Ubersetzungen fur council directive 93 42 eec of 14 june 1993 concerning medical devices im englischdeutschworterbuch, mit echten sprachaufnahmen, illustrationen, beugungsformen. Council directive 93 42 eec of 14 june 1993 concerning. 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. Details of the mdd 9342eec directive essential requirements. Annex ix 9342eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies.
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 ivd directive was amended and corrected over time. 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. Medical devices directive 93 42 eec try it for free on. 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. List european harmonized standards for the medical devices. Medical devices internal market, industry, entrepreneurship. Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of iso 485. Directives 90385eec and 9342eec medical devices clinical. 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.
B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. European medical device directive essential requirements. Medical device directive 9342eec latest amended by directive 200747ec terumo product related risk management documents en 15986. Manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. At the end of the course, you will be able to implement the requirements of the directive and to audit organizations against it. 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. Compliance with medical device directive 9842eec mdd. Directive 9879ec of the european parliament and of the council of 27 october 1998.
Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Please find the latest consolidated ivdd 9879ec below. This document is meant purely as a documentation tool and. 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 standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. 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. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. The revision of the medical devices directive 9342eec. 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. The medical device directive is intended to harmonise the laws relating to medical devices. This represents the minimum standard a manufacturer is expected to.
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. 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. 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. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. These sections are reproduced below for your information or. 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. F2 labs can perform the emc and safety testing that is required by the medical device directive for.
Classification criteria definitions for the classification rules. 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. Delivered inhouse, this 1day practical workshop provides an awareness of the european directive 9342eec concerning medical devices. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products.
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