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