Essential requirements annex i, 93 42 eec as compliance. 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 93 42 eec nrlcontaining medical devices i. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. 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 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. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. September 2007 council directive 200747ec 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. Download council directive 9342eec on medical devices mdd. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. Classification criteria definitions for the classification rules. 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.
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. Medical device directive mdd 9342eec as amended by 2007 42 ec pavan kumar malwade 01 april 2016 1 2. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. Manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. Essential requirements checklist mdd 93 42 eec background of annex x section 1. Council directive 9342eec of 14 june 1993 concerning. The ivd directive was amended and corrected over time. Iec 60601 medical electrical equipment safety standards series. Guidelines relating to the demarcation between directives 90385 eec, 93 42 eec and 6565 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. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products. The medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used.
B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. New european regulation for medical devices to replace 93. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. A medical device is defined in directive 93 42 eec as. The definition of the term medical device together with the definition of accessory is determinant for the delimitation of the field of application of directive 93 42 eec. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Essential requirements checklist mdd 93 42 eec misc. Compliance of medical devices with the new requirements according to article 2 of directive 93 42 eec, member states shall take all necessary steps to ensure that devices. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.
Medical devices directive 93 42 eec mdd and subsequent amendments. In order to avoid delays or interruption in the supply of medical devices as of 21 march 2010, manufacturers notably of a new type of medical device, devices that change their class due to the revised classification rules or. 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 directive 93 42 eec on medical devices mdd 93 42, is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices. Ec no 12232009 and repealing council directives 90385 eec and 93 42 eec, will consolidate two existing legal provisions and replace both the current medical device directive 93 42 eec and the active implantable medical device directive 90385 eec. This regulation also applies to clinical investigations conducted in the union concerning the products referred to in the first subparagraph. Official journal no page date m1 council directive 93 42 eec of 14 june 1993 l 169 1 12. Regulation eu 2017745 of the european parliament and of.
Council directive 93 42 eec of 14 june 1993 concerning medical devices, last amended by directive 200747ec. Quality assurance and business systems related topics. 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. New european regulation for medical devices to replace 9342.
Directive 200070ec of the european parliament and of the. European union 2 the eu is a unique economic and political partnership between 28 european countries that. References made to the medical device directives include the council directive. This free of charge application was designed to help manufacturers, consultants, notified. 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. Following the latter directive, accessories are by definition medical devices, whilst following directive 93 42 eec, a distinction is made between devices and. National institute of pharmacy and nutrition directorate of device testing and clinical engineering emki certifies that the following manufacturers. Medical devices directive 93 42 eec pdf download 10yi83. The medical device regulation mdr 2017745 will replace the eus current medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec.
Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Sanatmetal ortopediai es traumatol6giai eszkiziket gyart6 kft. Conformity with medical device directive 9342eec is mandatory all. Devices shall be divided into classes i, iia, iib and iii. 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. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. 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. Classification shall be carried out in accordance with annex ix. Questions relating to the implementation of directive 200747 ec 1. Directive 200070ec of the european parliament and of the council of 16 november 2000. A slight difference exists between the definition in article 12 a of directive 93 42 eec and in article 12 of directive 90385 eec.
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. Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020. Council directive 9342eec of 14 june 1993 concerning medical devices. Please find the latest consolidated ivdd 98 79 ec below. Essential requirements annex i, 9342eec as compliance. In order to comply with the european union eu medical device directives 90385 eec active implantable medical directives aimd, 93 42 eec medical device directive mdd and 9879ec in vitro diagnostics device directive ivdd referred to as the directives hereafter, manufacturers must conduct postmarket surveillance pms. Medical devices directive 9342eec requirements for. Medical device directive 9342eec cemarking qnet, llc. Guidelines for classification of medical devices ce marking. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Whereas council directive 90385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90385eec. Medical devices are grouped into four product classes. Council directive 9342eec on medical devices mdd 1993.
Medical devices directive 93 42 eec medical electrical equipment part 249. Commission communication in the framework of the implementation of the council directive 93 42 eec concer ning medical devices publication of titles and references of har monised standards under union har monisation legislation text with eea relevance 2017c 38903 eso 1 reference and title of the standard. 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. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. B council directive 9342eec of 14 june 1993 concerning. Consolidated medical device directive 93 42 eec interactive web page. 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 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.
European commission enterprise and industry medical devices directive 93 42 eec short name. Products within the scope of mdd article 1 of the directive defines a medical device to mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used. The classification rules of medical devices, as established in annex ix of directive 93 42 eec 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. 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. 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. Medical devices directive 93 42 ec evaluation and testing.
Directive 90385 eec regarding active implantable medical devices aimd directive 93 42 eec regarding medical devices mdd directive 9879ec regarding in vitro diagnostic medical devices ivdd all medical devices must fulfil the essential requirements set out in the above mentioned directives. If the appliance is at the same time a medical device within the meaning of directive 9342eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this directive. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Medinfo medinfo council directive 9342eec on medical devices. Medical device directive mdd including amendments, the latest being directive 200747ec. 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. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking. Classification criteria definitions for the classification. Where not selfevident, the manufacturer should document the rationale for classifying as a medical device classification according to en iso 109931 annex a.
The medical device regulation mdr has entered into force on may 26th 2017. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90385 eec. Council directive 90385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, last amended by directive 200747ec. Active implantable medical devices directive 90385eec try it for free on. Europa enterprise guidelines on the implications of the. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Council councildirective93 eec42 14of june1993 concerningmedicaldevices thecouncil of theeuropean communities, having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereofhaving, regard tothe proposalfromthe commission, incooperation withthe2european parliament. 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 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.
Because of the many types of devices covered by the mdd, the specific requirements depend on the. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission. Directive 9342eec on medical devices, annex ii 4 no. Mdd 93 42 eec article 9 medical device classification 1. 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. Active medical device any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices internal market, industry, entrepreneurship. M5 stand alone software is considered to be an active medical device. European medical device directive essential requirements. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385 eec oj l 189, 20.
The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes. Europa enterprise guidelines on the implications of. 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. Council directive 93 42 eec of 14 june 1993 concerning medical devices. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. F2 inserted 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 of. Directive of active implantable medical devices 9879ec.
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