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. Overview a medical device is defined in directive 9342eec as. Medical devices directive 93 42 eec medical electrical equipment characteristics of digital xray imaging devices part. How are medical devices regulated in the european union. We, vicon motion systems limited unit 14 minns estate oxford ox2 0jb united kingdom. Directive 93 42 eec since 1 december 2018 the references of harmonised standards are published in, and withdrawn from the official journal of the european union by means of commission implementing decisions. Council directive 93 42 eec on medical devices mdd 1993 council directive 9879ec on in vitro diagnostic medical devices ivdmd 1998 new regulations on medical devices. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. 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. The content of this page deals only with the medical devices directive 9342eec.
Council directive 93 42 eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. A manufacturer who wishes to sell medical devices on the eu market must meet the regulations of the medical device directive 93 42 eec. Electromagnetic compatibility to emc directive 201430eu electrical safety to low voltage directive 201435eu. Medical devices directive 9342eec breathing system filters for anaesthetic and respiratory use part 2. 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 98 79 ec. 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. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Hundreds of experts are already using this software. The following stepbystep plan has been drawn up for the manufacturer. 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 applies for the placing on the market and launching of medical devices and their accessories. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Council directive 9342eec of 14 june 1993 concerning. In the interests of clarity and rationality the said directive should be codified. The directive 9342 eec applies for the placing on the market and launching of medical devices and their accessories. Essential requirements annex i, 9342eec as compliance. The number indicates the year of initial release 1993 and the consecutive number of directives in that year. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. If the appliance is at the same time a medical device within the meaning of directive 9342 eec 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 covers the placing on the market and putting into service of medical devices within the framework of ce marking. Essential requirements checklist mdd 93 42 eec background of annex x section 1. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Is standalone software considered as a medical device. 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. F1 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. Medical device directive 93 42 eec mdd annex ix classification criteria medical devices directive explained how medical devices are regulated in europe i. European medical device directive essential requirements. New eu mdr regulations and revamp of the medical device directive. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Directive 9342 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 devicesintroduction introductionarticle 1 definitions, scopearticle 2 placing on the market and putting into servicearticle 3 essential requirementsarticle 4 free movement, devices intended for special purposesarticle 5 reference to standardsarticle 6 committee on standards and technical regulationsarticle 7 article. Medical devices directive 93 42 eec pdf download 10yi83. Medical devices directive 93 42 eec as amended by eu council directive 200747ec of 5th september 2007.
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. Software, which drives a device or influences the use of a device, falls automatically in the same class. 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. 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. To prove that your device complies with the essential requirements of these ce directives, you need to affix a ce mark to it. Medical devices internal market, industry, entrepreneurship. List european harmonized standards for the medical devices. Mdd annex ix classification criteriapresentationeze. Duration transient normally intended for continuous use for less than 60 minutes. For that purpose, your product needs to go through the ce marking process. 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.
Council directive 9342eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. Please find the latest consolidated ivdd 9879ec below. As a notified body under the medical devices directives, we have one of the broadest. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. European medical devices directive 9342eec with 200747ec. The ivd directive was amended and corrected over time. Medical device under meaning of the directive 9342eec 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 for its proper application, intended by the manufacturer to be used for. European national states must translate this directive into national law. 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 biocidal. Economic pressure spurred the development of the first directive which had two goals 1 the harmonisation of the law and 2 dealing with the problems caused by the need for interoperability. On 5 april 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. The classification of medical devices in the european union is outlined in annex ix of the council directive 93 42 eec.
Council directive 93 42 eec of 14 june 1993 concerning medical devices. Directive of the european parliament and of the council of 5th 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 biocidal prodcuts on the. Classification criteria definitions for the classification rules. The 200747ec amendment was established on september 5, 2007 and the consolidated directive became mandatory on march 21, 2010. They entered into force on 25 may 2017 and will progressively. In that case, of importance are the medical device directives mdd. Medical device directive 93 42 ewg mdd the mdd is the medical device directive or 93 42 eec. The medical devices directive 9342 eec contains the legal obligations for each type of economic operators manufacturer, importer, distributor.
According to the aforementioned article, a medical device is defined as follows. Medical devices directive 9342eec try it for free on. 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. Definitions definitions for the classification rules. Medical devices directive 9342eec pdf download 10yi83. The first eu directive on the legal protection of computer programs was council directive 91250 eec of 14 may 1991. For devices falling under directive 93 42 eec other than custommade devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules see articles 9 and 11 of directive 93 42 eec. The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. 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 content of council directive 91250 eec of 14 may 1991 on the legal protection of computer programs 3 has been amended 4. The medical devices directive applies to medical devices, accessories and medical software medical device is defined as instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of desiases, injuries or. Apr 14, 2017 further, it must be determined whether the standalone software falls within the scope of a medical device in accordance with article 1.
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