Council directive 9342eec of 14 june 1993 concerning medical devices. Medical devices directive 93 42 eec medical devices utilizing animal tissues and their derivatives part 1. 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. Medical devices 93 42 eec mdd, directive on active implantable medical devices 90385 eec aimdd, and directive on in vitro diagnostic medical devices 9879ec ivdd. The main differences between the directive and the regulation are as follows. Dolomitelegacy 1 general tips and recommendations gives useful tips, recommendations and information for efficient, trouble free use. Europa enterprise guidelines on the implications of. The medical devices directive mdd applies to all general medical devices not covered by the active implantable medical devices directive or the in vitro diagnostic medical devices directive. Mdd 9342ec classification rules but the new one, the eu medical device. Medinfo council directive international expert information. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 93 42 eec and the active implantable medical devices directive aimdd 90385 eec.
Eu 2017745 a device which is a class i device pursuant to directive 93 42 eec, for which the declaration of confor mity was drawn up pr ior to 26 may 2020 and. 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 93 42 eec mdd and active implantable medical devices directive 90385 eec aimdd. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Medical devices guidance document classification of. Free movement, devices intended for special purposes. It 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. Directive 2006 42 ec makes provisions for partially completed machinery in a. The medical devices directive mdd is a european ce directive that is replaced by the regulation eu 2017745. Dolomite legacy user manual pdf download manualslib. Medical devices guidance document classification of medical. The mdr, which replaces the medical devices directive 93 42 eec and active implantable medical devices directive 90385 eec, has a transition period of three years.
Machines powered by human effort are not specifically excluded, nor are medical devices but the latter are already covered by the medical devices directive 93 42 eec. Medinfo medinfo council directive 9342eec on medical devices. Why a nb change from annex ii of mdd 93 42 eec to annex v. 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. Guide to medical device directive compliance 9342eec. 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 face masks requirements and test methods purpose. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. As notified body for medical devices, our identification number is 0123. The medical device directive 93 42 eec mdd lists the essential safety, efficacy and quality requirements that a medical device must meet in order to be ce marked and placed on the european market. Commission communication in the framework of the implementation of the council directive 93 42 eec concer ning medical devices. 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. 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 pdf download 1obpox.
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. Download from the link below the mdr in the main european languages. Invitro diagnostic devices directive 9879ec directive 9879ec on in vitro diagnostic medical devices interactive web page. Medical devices directive 199342 eec ente certificazione. Mdr medical devices regulation eu 2017745 mdi europa. Devine guidance for complying with the european medical device. 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. This free of charge application was designed to help manufacturers, consultants, notified. The content of this page deals only with the medical devices directive 93 42 eec. Notified bodies are free to offer their conformity assessment services for which. Download council directive 9342eec on medical devices mdd. Pdf how amendments to the medical device directive. Click here to download a pdf version of the invitro diagnostic devices directive 9879ec directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices introduction introduction article 1 scope, definitions article 2 placing on the market and putting into service article 3 essential requirements article 4 free movement.
Ec no 12232009 and repealing council directives 90385eec and 93 42 eec text with. Final medical device regulations replacing mdd 93 42 eec, etc. There is a transition period of 3 years making the regulation fully applicable on may 26, 2020. 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. Europa enterprise guidelines on the implications of the. It is amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices, last amended by directive. The medical devices directive 93 42 eec classifies products according to their level. 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. Pdf the new medical device regulations of european union replace the e. Directive 93 42 eec and be subject to a consultation of a pharmaceuticals authority in accordance with point 7. Medical device means 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 specifically for diagnostic andor therapeutic purposes and necessary. Medical devices directive 93 42 eec needle free injectors for medical use requirements and test methods. Directive 93 42 eec on medical devices eu mdd directive 9879ec on in vitro diagnostic medical devices eu ivdd from 1 july 2023, a ukca mark will be required in order to place a device on the.
General medical devices the great majority of products this legislation is implemented and enforced in each eu member state by a competent authority. Directives and in particular of the medical device directive 9342eec mdd. Protective garments that were identified as medical devices, now became ppe as well. Clinical evaluation requirements of the medical devices directive 93 42 eec. 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. Conformity with the medical devices directive is a mandatory requirement for ce marking your medical device to access to the european single market. Directive 93 42 eec medical devices directive active implantable medical devices directive. In the uk the competent authority is the medicines and healthcare products regulatory agency mhra. 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. Requirements and testing for shelf life determination purpose.
Guide to medical device directive compliance 9342eec instrktiv. The conformity of medical devices and invitro diagnostic medical device according to european union directives 93 42 eec, 90385 eec and 9879 eec must be assessed before sale is permitted. Directive medical devices directive 93 42 eec last official journal reference wednesday 25th of march 2020 description. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Medical devices directive 93 42 eec mdd and subsequent amendments. Medical devices directive 93 42 ec evaluation and testing. B council directive 9342eec of 14 june 1993 concerning. Medical devices directive 93 42 eec try it for free on. Medical device directive mdd 93 42 eec as modified by 200747ec. Manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. Article 1 of the directive defines a medical device. Or download the pdf of the directive or of the official journal for free. Medical devices directive 9342eec is due to be replaced in 2021. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products.
Wider and clearer scope of eu legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests. 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. 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. Medical device directive mdd 93 42 eec as amended by 200742ec pavan kumar malwade 01 april 2016 1. 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. A medical device is defined in directive 93 42 eec as. Medical devices may only bear the ce marking if the essential requirements. Basic information about the european directive 9342eec on. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. Medical device directive mdd 9342eec as modified by 2007. Overview a medical device is defined in directive 93 42 eec as.
Robert packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. Learn how to classify medical devices in europe with our free medical. Council directive 93 42 eec on medical devices mdd 1993. 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. The medical devices directive is due to be replaced by the medical devices regulation in 2021. We are able to provide you with the legally required.
Interpretative document of the commissions services. Us current medical device directive 93 42 eec and the e. 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. The following products are classified as medical device. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories.
One of the major requirements to prove conformity is the implementation of the quality management system according iso 9001 andor iso 485 and iso 14971. 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. The current eu regulatory framework for medical devices, other than in vitro diagnostic medical devices, consists of council directive 90385 eec on active implantable medical devices aimdd1 and council directive 93 42 eec on medical devices mdd2 which cover a huge spectrum of products. Step 2 determine classification of your device using annex ix of the medical devices directive mdd. Council directive 9342eec of 14 june 1993 concerning medical devices publication metadata download and languages close. Medical devices directive testing mdd 9342eecf2 labs. Clinical evaluation and investigation as part of the essential requirements, a clinical evaluation in accordance with annex x must be conducted for all medical devices. Medical devices directive 93 42 eec last official journal reference wednesday 25th of march 2020. Manufacturers have the duration of the transition period to update their technical documentation and. Download declaration in word or pdf format, with your logo.
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination. Council directive 9342eec of 14 june 1993 concerning medical devices publication metadata. Because of the many types of devices covered by the mdd, the specific requirements depend on the. The new doa of may 26, 2021 was approved by the european parliament in an amendment to the original regulation. Determine which eu medical device directive applies to your device. Mdd the medical devices directive product assurance by dnv gl. Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in council directive 89686 eec and. Council directive 93 42 eec of 14 june 1993 concerning medical devices. 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. Medical devices directive mdd has a wide scope and its purpose is to ensure free movement of safe medical devices within the eu community. 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. Directive 2006 42 ec makes provisions for partially completed machinery in a procedure that is outlined in article. Directive 200747ec guidance document for mdd 9342eec.
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