Directive 93 42 eec on medical devices pdf free

Medical devices directive 93 42 eec breathing system filters for anaesthetic and respiratory use part 2. Medical devices directive 9342eec sterile, singleuse intravascular catheters part 1. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Council directive 9342eec concerning medical devices. This free of charge application was designed to help manufacturers. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Download declaration in word or pdf format, with your logo. Conformity with medical device directive 9342eec is mandatory all devices. Requirements and testing for biological evaluation purpose.

Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. F8 deleted 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. 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 communication refers to article 224 of directive. Directive medical devices directive 9342eec last official journal reference wednesday 25th of march 2020 description. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. The regulation of medical devices facilitates the free circulation of these goods in. The regulation of medical devices in the european union. Annex 9 directive 9342eec amended, concerning medical devices. Official journal of medical devices directive 9342eec try it for free on. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. 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 9342eec as well as additional services regarding the marketing of your medical devices within the european community.

The european medical device regulati on 2017745 mdr 1 passed the european parliament. 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. Download mdr free mdr gap analysis mddmdr resources. Medical devices guidance document classification of.

Council directive 9342eec of 14 june 1993 concerning. 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. 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. The ivd directive was amended and corrected over time. Normally intended for continuous use for more than 30 days. Europa enterprise guidelines on the implications of.

Directive of active implantable medical devices 9879ec. Read online list of bodies notified under directive. 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 for classification of medical devices ce. Directive 90385eec on active implantable medical devices directive 9342eec on medical devices directive 9879ec on in vitro diagnostic medical devices ivds same rules applied for the whole eu transposed into national legislation free circulation of medical devices within the eu. Directive 9879ec of the european parliament and of the council of 27 october 1998. Please find the latest consolidated ivdd 9879ec below.

Medical device directive 9342eec cemarking qnet, llc. Final medical device regulations replacing mdd 93 42 eec, etc. Mdd 9342eec consolidated 2007 page 155 this document is meant purely as a documentation tool and the institutions do not assume any liability for its contents council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. Free movement, devices intended for special purposes. Council directive 9342eec of 14 june 1993 concerning medical devices. Information about mercury in thermometers and blood pressure devices pdf. Because of the many types of devices covered by the mdd, the specific requirements depend on. Pdf the european medical device regulation 2017745eu. Council directive 93 42 eec 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. 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. Compliance of medical devices with the new requirements according to article 2 of directive 9342eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if.

Understanding the medical devices directive 9342eec directive 9342eec 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 medical device directive is intended to harmonise the laws relating to medical devices. Medical devices directive 9342eec pdf download 10yi83. 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. 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. Guidelines relating to the demarcation between directives 90385eec, 9342eec and 6565eec.

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 200070ec of the european parliament and of the council of 16 november 2000. If you define your product as a medical device, before you can market it in the eu, your product must meet the essential requirements in annex i of the medical devices directive mdd9342eec. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Eu medical device directive 9342eec labelling requirements. Medical devices directive 9342eec breathing system filters for anaesthetic and respiratory use part 2. Ce marking in medical devices, 9342at, 200747ec szutest. Guide to the regulation of medical devices swissmedic. Medical devices directive 9342eec biological evaluation of medical devices part 12.

Why a nb change from annex ii of mdd 93 42 eec to annex v. B council directive 9342eec of 14 june 1993 concerning. 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. 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. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. 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.

Regardless of the class a device belongs to, the manufacturer is obliged to prepare a technical file for the respective device or device family. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. All books are in clear copy here, and all files are secure so dont worry about it. 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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12.

The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise. Or download the pdf of the directive or of the official journal for free. The medical device directive,published by the european commission from the. Questions relating to the implementation of directive 200747 ec 1. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. 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. 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. 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. Sample preparation and reference materials iso 1099312.