Council directive 9342eec of 14 june 1993 concerning medical devices. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Medical devices 9342cee and active implantable medical. 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. Personnel responsible for quality systems for medical device manufacturers will benefit from this. These sections are reproduced below for your information or. Medical device directive mdd 9342eec as modified by 200747ec. The takeaway from this weeks edition on mdd annex x clinical.
Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Classification criteria definitions for the classification. Medical devices directive 9342eec mdd and subsequent amendments. Medical devices internal market, industry, entrepreneurship. Bsi training european medical devices directive requirements.
Medical device directive 93 42 eec mdd annex i essential requirements medical devices directive explained how medical devices are regulated in europe i. Council directive 9342eec of 14 june 1993 concerning medical devices direttiva 9342cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici oj l 169, 12. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. 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. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Annex xvii, article, correlation table, council directive 90385eec, council directive 9342eec, mdr annex xvii. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Annex of the directive, conformity assessment procedure, ec certificate. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and. Classification of md acc mdd 9342eec annex ix product. As a manufacturer of active and nonactive medical devices, you cannot market your products on the european market unless you meet the basic requirements ec directive 9342eec mdd, annex i.
New european regulation for medical devices to replace 93. Mdd, 9342eec or the active implantable medical devices directive aimd, 90385eec are included in the mdr. Essential requirements ers of directive 9342eec included in annex za of en iso 11607 8. The mdr will replace the current eus medical device directive 9342eec and the. Medical devices mdd 9342cee and active implantable medical devices. Directive 9342eec, as amended, allows for derogation from the classification rules outlined in its annex ix in light of technical progress or on information gathered from. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. Medical devices with wireless features are also subject to the new radio equipment directive red 201453eu, which sets standards for all wireless devices marketed in the eu. The references published under directive 93 42 eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below. 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. Because of the many types of devices covered by the mdd, the. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime.
Ce marking directive 90385cee as amended available in the download. Council directive 9342eec medical device regulation. 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. Eu medical device directive 9342eec labelling requirements. The european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. Essential requirements checklist medical device academy. If all these conditions are fulfilled, directive 9342eec applies.
There are a few changes to the classification rules under. Council directive 9342eec archives medtech intelligence. Details of the mdd 93 42 eec directive essential requirements. Classification criteria definitions for the classification rules. B council directive 9342eec of 14 june 1993 concerning. Just like analog medical devices, wireless medical devices are regulated by the medical device directive 9342eec, provided that they are sold in the eu. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Essential requirements checklist mdd 9342 eec background of annex x section 1. Mdr medical devices regulation eu 2017745 regulation eu 2017745 also known as the medical devices regulation mdr has been adopted on may 25, 2017 and will replace the medical devices directive 9342eec mdd and active implantable medical devices directive 90385eec aimdd. 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.
Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec text with eea relevance. Annexes to this directive, including any reference to minimizing or. 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. Mdd annex ix classification criteriapresentationeze. For complex medical devices risk analysis is sometimes required to be in compliance with iso14971 and or mdd9342eec medical device directive for the european economic community. A medical device is defined in directive 93 42 eec as. Medical device directive 9342eec cemarking qnet, llc. According to mdd annex ix 9342eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies. Medical devices guidance document classification of medical.
The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Technical file ce marking consultants ce marking mdd. Active and nonactive medical devices us tuv rheinland. Directive 200747ec guidance document for mdd 9342eec. Beginning on 21 march 2010, notified bodies can no longer issue unlimited ce marking certificates mdd 9342eec annexes v and vi plus aimdd 90385eec annex v which will be limited to a maximum of five years. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the. Mar 10, 2015 the path to market approval for a medical device in the eu is no simple decision for a manufacturer to make. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Directive 9879ec of the european parliament and of the council of 27 october 1998. The member states shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in annex xi. 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 xii ce marking of conformity of the medical device directive is all about the mark, the whole mark, and nothing but the mark. 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 by the manufacturer.
Long term normally intended for continuous use for more than 30 days. Medical device directive 9342eec the medical device directive 9342eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. Council directive 93 42 eec of 14 june 1993 concerning medical devices. 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. 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 be used for human beings for the purpose of. For products classified with medium to high degree of risk class is, im, iia, iib and iii the medical device directive requires a conformity assessment procedure involving a notified body. Mdr medical devices regulation eu 2017745 mdi europa.
Directive 9342eec, as amended, allows for derogation from the classification rules outlined in its annex ix in light of technical progress or on information gathered from postmarket experience with the device. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Finally, you must verify that no other exclusion clause contained in the first article of directive 9342eec is applicable. European union 2 the eu is a unique economic and political partnership between 28 european countries that. The notified body shall provide all relevant information on request. Duration transient normally intended for continuous use for less than 60 minutes. In this article we will attempt to explain iso14971 risk analysis. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 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. 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.
This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90385eec and 9342eec. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. Also, prior to 21 march 2010, existing unlimited certificates need to be reissued with a limited validity that has considered directive. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products. Understanding the annexes for medical devices ce marking.
Medical devices directive 9342eec european commission. Council directive 9342eec of 14 june 1993 concerning. Definitions definitions for the classification rules. Directive 200070ec of the european parliament and of the. 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. European medical device directive essential requirements. Rule 2 all noninvasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion. The scope has also been extended to include a number of additional devices. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Posts tagged council directive 9342eec massimop z annex 17 xvii correlation table annex, annex xvii, article, correlation table, council directive 90385eec, council directive 9342eec, mdr.
Download declaration in word or pdf format, with your logo. The medical devices directive, for almost every device class, gives manufacturers a choice as to which conformity assessment they would like to use. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. 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. 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. In laymans terms, the design dossier is the technical documentation plus a summary of the history of design changes for. Short term normally intended for continuous use for not more than 30 days. Having regard tothe treatyestablishing the european economic. 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. 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. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Medical device directive 93 42 eec mdd annex ix classification criteria medical devices directive explained how medical devices are regulated in europe i. Medical device directive 93 42 eec the medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of.
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