The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Medical devices guidance document classification of medical. 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 first edition of this standard was drafted in a period when the active implantable medical device directive aimdd90385eec and the medical device directive mdd9342eec were relatively new and the in vitro diagnostic medical. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. The content of this page deals only with the medical devices directive 93 42 eec. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. 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. The directive 9342eec on medical devices mdd 9342, is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices. Council directive 9342eec of 14 june 1993 concerning medical devices eu law. Conformity with medical device directive 9342eec is mandatory all devices that fit the definition of a.
Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Download the most important ce product guidelines here. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Medinfo medinfo council directive 9342eec on medical devices. Guidelines for classification of medical devices ce. If the ancillary substance is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines, the notified body must seek a. 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.
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 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Medical devices directive 93 42 eec pdf download 10yi83. Essential requirements checklist mdd 93 42 eec background of annex x section 1. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Medical devices directive 93 42 eec cardiovascular implants endovascular devices part 1. Council directive 9342eec of 14 june 1993 concerning medical devices. Medical devices directive 9342eec european commission. Directive 9342eec relating to medical devices, published in oj 98c 24205. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Directive 200070ec of the european parliament and of the council of 16 november 2000. Directive of active implantable medical devices 9879ec. Directiveeec directive, directive devices markingthe.
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. Read online list of bodies notified under directive. Medical devices directive 93 42 eec medical electrical equipment part 249. Council directive 9342eec of 14 june 1993 concerning. Having regard tothe treatyestablishing the european economic. The european medical device regulati on 2017745 mdr 1 passed the european parliament. This document is available in either paper or pdf format.
This regulation lays down rules concerning the placing on the. Trade 9342eec medical devices directive, ce marking for europe manufacturers of class i sterilemeasuring, iia, iib and iii devices must obtain certification against the ce marking directive, 9342eec, from a notified body before using the ce mark and placing products on the market. Medical devices directive 9342eec cardiovascular implants endovascular devices part 1. Active implantable medical devices directive 90385eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices eu law. 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.
Classification criteria definitions for the classification rules. Eu medical device directive 9342eec labelling requirements. The classification of the medical device will have an impact on the conformity assessment route that the manufacturer should follow in order to affix the ce marking on. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories.
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. As regards ar ticle 1684c tfeu, this regulation sets high. M5 stand alone software is considered to be an active medical device. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. B council directive 9342eec of 14 june 1993 concerning.
As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. 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. Essential requirements checklist mdd 9342 eec background of annex x section 1. Directive 90385 eec of 20 june 1990 on the approximation of laws relating to active implantable medical devices 1 and council directive 93 42 eec of 14 june 1993 concerning medical devices 2 with the exclusion of in vitro diagnostic medical devices. Medical devices directive 9342eec medical electrical equipment part 249. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Directive 90385eec of 20 june 1990 on the approximation of laws relating to active implantable medical devices 1 and council directive 9342eec of 14 june 1993 concerning medical devices 2 with the exclusion of in vitro diagnostic medical devices. The first edition of this standard was drafted in a period when the active implantable medical device directive aimdd90385 eec and the medical device directive mdd 93 42 eec were relatively new and the in vitro diagnostic medical. Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of directive 9342eec. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. Medical devices guidance document classification of.
The essential requirements of the medical device directive 93 42 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. 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. Basic information about the european directive 9342eec. Medical devices directive 93 42 eec try it for free 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.
Guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec. Medical devices directive 9342eec try it for free on. Commission communication in the framework of the implementation of the council directive 93 42eec concer ning medical devices. Download council directive 9342eec on medical devices mdd. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. F8 deleted by 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 active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of. Overview a medical device is defined in directive 93 42 eec as. 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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Pdf the european medical device regulation 2017745eu. All books are in clear copy here, and all files are secure so dont worry about it. 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. The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes. Manufacturers have the duration of the transition period to update their technical documentation and.
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. Download declaration in word or pdf format, with your logo. 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. Conformity with medical device directive 9342eec is mandatory all devices. These products fall under the medical devices legislation and must be ce marked. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. 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. Commission communication in the framework of the implementation of the council directive 93 42eec 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. 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. Whereas council directive 90385eec 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. Classification criteria definitions for the classification. 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 active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal products on the market text with eea relevance. Download from the link below the mdr in the main european languages.
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. Because of the many types of devices covered by the mdd, the specific requirements depend on the. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. 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. Directiveeec directive,directive devices markingthe. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. Information supplied by the manufacturer of medical devices format. 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 device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. The medical device directive 9342eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Medical device directive 9342eec cemarking qnet, llc. Commission communication in the framework of the implementation of council directive 9342eec concerning medical devices text with eea relevance. Medical devices internal market, industry, entrepreneurship. 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. This directive shall apply to medical devices and their accessories.