Or download the pdf of the directive or of the official journal for free. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. The new europe eu medical device regulations mdr published by the european commission on may 5, 2017 revamped major portions of the eu medical device directive mdd, raising compliance bars for all device manufacturers, economic operators and notified bodies. Commission directive 200550ec of 11 august 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of council directive 9342eec concerning medical devices text with eea relevance. 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 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 manufacturer should first decide if the product concerned is a medical device as defined in directive 9342eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. The guidelines deal with specific issues in the context of the aforementioned. Please enter a short name of your company so that we can allocate the documents you submitted. These guidelines should be read in conjunction with the directive 90385 eec relating to active implantable medical devices and the directive 93 42 eec relating to medical devices. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation. Mednet as your authorized representative for medical devices acts as your legal entity towards the european authorities and fulfills on your behalf the obligations described in the medical device directive mdd 93 42 eec as well as additional services regarding the marketing of your medical devices within the european community. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to. Machines powered by human effort are not specifically excluded, nor are medical devices but the latter are already covered by the medical devices directive 9342eec. How are medical devices regulated in the european union. Council directive 9342eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385eec and 9342eec with respect to. 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 93 42 eec of 14 june 1993 concerning medical devices. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. 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. Graham clements page 2 of 6 introduction compliance of protective garments with the medical devices directive 93 42 eec or the personal protective equipment ppe directive 89686 eec was originally a choice between the two when the directives were first issued. Directive 200642 ec makes provisions for partially completed machinery in.
Application for performancechangeextension of a conformity. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 9342eec last amended by directive 200747ec annex i, section 7. B council directive 9342eec of 14 june 1993 concerning. The classification rules of medical devices, as established in annex ix of directive 9342eec on medical devices, depend on the vulnerability of the human body, taking into account possible dangers inherent in the technical design and manufacture of the devices.
New eu mdr regulations and revamp of the medical device. Council directive 9342eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. Manufacturers have the duration of the transition period to update their technical documentation and. 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. The european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. The regulation has significant economic impact on manufacturers, due to the cost of. 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. 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. 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. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. To enable your organization to achieve ce marking certification sgs is notified body 0120 under directive 93 42 eec for all devices including drug device combinations and associated directives 200332ec animal tissue, 200550ec total joint implants and 200747ec amendments.
This document is meant purely as a documentation tool and. Directive 9368eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. European medical device directive essential requirements. Ce marking in medical devices, 9342at, 200747ec szutest. Council directive 9342eec on medical devices, 20 o. When considering the medical device, the criteria for risk acceptability is.
New european regulation for medical devices to replace 93. Pdf the european medical device regulation 2017745eu. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Qualified person 9102014 d in the case of investigational devices, that the statement referred to in point 4.
The council directive 90385eec on active implantable medical devices the council directive 9342eec on medical devices definition of medical devices definition of accessory. Council directive 9342eec 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. There are three medical device directives in place, the directive of active implantable medical devices 90385 eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. Unit 4 pressure equipment, medical devices, metrology medical devices. New european regulation for medical devices to replace 9342. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on. Celab performs voluntary inspection activities on technical construction files to check their contents. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. This documentation demonstrates compliance with essential requirements annex i of the 9342eec. Annex ix of the mdd defines the classification rules for europe. Medical face masks requirements and test methods publication. Medical devices guidance document classification of.
In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Annexes i to x to directive 9342eec, and annex i to x to directive 9879ec to be construed as a reference to those provisions as are amended from time to time. The council of the european communities, having regard to the treaty establishing the european economic community, and in. Class i devices, that are non sterile and nonmeasuring, do not require a notified body nb. Medical device directive 93 42 eec mdd annex i essential requirements medical devices directive explained how medical devices are regulated in europe i.
Understanding the medical devices directive 93 42 eec 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. These three legal texts form the core legal framework for medical devices. Medical devices are classified on a riskbased system. European commission enterprise and industry medical devices directive 93 42 eec short name. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. This directive shall apply to medical devices and their accessories. Please find the latest consolidated ivdd 98 79 ec below. Medical device directive 9342eec cemarking qnet, llc. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal. Medical devices are products or equipment intended generally for a medical use. The qualified person qp shall suffer no disadvantage within the manufacturers organization. Council directive 9342eec of 14 june 1993 concerning medical. 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.
In the context of medical devices directive 9342ec mdd and this. All books are in clear copy here, and all files are secure so dont worry about it. Medical devices guidance document classification of medical. Directive 90385eec of 20 june 1990 on the approximation of laws relating to active implantable medical devices 2 and council directive 9342eec of 14 june 1993 concerning medical devices 3 with the exclusion of in vitro diagnostic medical devices. Medical devices directive 9342 eec try it for free on. Download b council directive 9342eec of 14 june 1993 concerning. With respect to the european medical devices directive 9342eec notified bodies are entitled to perform product as well as quality system management related conformity assessment procedures as outlined in article 11 and the annexes ii, iii, iv, v, vi and vii of this directive. Note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. Read online b council directive 9342eec of 14 june 1993 concerning.
Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. Medinfo medinfo council directive 9342eec on medical devices. They provide a practical support for the uniform application of these directives. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents.
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 medical device. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal products on the market. Harmonized european standards, available for a fee. This applies for medical devices requiring the ce mark in europe. Commission implementing regulation eu no 92020 of 24 september 20 on the designation and the supervision of notified bodies under council directive 90385eec on active implantable medical devices and council directive 9342eec on medical devicestext with eea relevance. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. 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 ivd directive was amended and corrected over time. European commission enterprise and industry medical devices directive 9342eec short name. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating stable derivates of. Software as a medical device part ii in compliance magazine.
The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. But the pacs system that manages dicom files may be a medical device. The preferred document format is pdf files with bookmarks for ease of locating specific content. 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 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. 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. Defines safety and reliability requirements for medical equipment. Provisions of directive 200747ec directive 200747ec amends directive 90385eec on active implantable medical devices and directive 9342eec on medical devices. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 9342eec annex ix. Mdd the medical devices directive product assurance by dnv. 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. Directive 9342eec as amended concerning medical devices. 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.
Protective clothing and medical devices certification manager. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for. Council directive 93 42 eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Basic information about the european directive 9342eec. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. 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. Medical devices internal market, industry, entrepreneurship. The mdr will replace the current eus medical device directive 9342eec and the. 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.
In accordance with section 115 of the consumer protection act 1987, he has consulted such. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Medical devices directive 9342eec mdd and subsequent amendments. Medical devices can be placed on the market or put into service only if they meet the requirements of directive 93 42 cce and of the directive 90385 eec and as amended which are intended to ensure the safety and health protection of patients, users and any third parties during the use of these products. The manufacturer should first decide if the product concerned is a medical device as defined in directive 93 42 eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive.
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