93 42 eec medical devices pdf files

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. All books are in clear copy here, and all files are secure so dont worry about it. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Harmonized european standards, available for a fee.

Council directive 9342eec of 14 june 1993 concerning. Because of the many types of devices covered by the mdd, the specific requirements depend on. Medinfo medinfo council directive 9342eec on medical devices. Protective clothing and medical devices certification manager. 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. Ce marking in medical devices, 9342at, 200747ec szutest. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending.

New european regulation for medical devices to replace 9342. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. Directive 9368eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. Please enter a short name of your company so that we can allocate the documents you submitted. Where not selfevident, the manufacturer should document the rationale for classifying as a medical device classification according to en iso 109931 annex a. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Final version of the european medical device and ivd regulations published on 5 may 2017. For all classes of medical devices i, iia, iib, iii the manufacturer must have and keep uptodate a technical documentation, also called a technical file or a device master file. These are, for example, additional equipment or singleuse devices. The guidelines deal with specific issues in the context of the aforementioned directives.

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. 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 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 manufacturer. European medical device directive essential requirements checklist. The current european union eu regulatory framework governing medical devices includes council directive 90385eec on active implantable medical devices and council directive 9342eec on medical devices. The devices must be designed, manufactured and packed in such a way that their characteristics and. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Consolidated medical device directive 9342eec interactive web page. The manufacturer should first decide if the product concerned is a medical device as defined in directive 9342eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. Contents of technical documentation for mdd 9342eec and ivdd 9879ec pdf. Title compliance with medical device directive 9842eec mdd description the course is designed to give you an understanding of the requirements of the medical device directive 9342eec as amended in 200747ec. At the end of the course, you will be able to implement the requirements of the directive and to audit organizations against it. Understanding the medical devices directive 93 42 eec 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.

At the end of the course, you will be able to implement the requirements of. The guidelines deal with specific issues in the context of the aforementioned. 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. 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. In vitro diagnostic medical devices are governed by directive 9879ec. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 9342eec as regards medical devices incorporating stable derivates of human blood or human plasma. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission.

Medical device 9342eec certification if you want to enter european economic area with your product qualified as medical device, ce marking is the only way how to proceed. Application for performancechangeextension of a conformity. Graham clements page 2 of 6 introduction compliance of protective garments with the medical devices directive 9342eec or the personal protective equipment ppe directive 89686eec was originally a choice between the two when the directives were first issued. The european parliament and council directive 9342eec has been implemented in order to unify marketing rules over each member state in the meaning of single common market. Title compliance with medical device directive 98 42 eec mdd description the course is designed to give you an understanding of the requirements of the medical device directive 93 42 eec as amended in 200747ec.

Medical devices guidance document classification of. The manufacturer should first decide if the product concerned is a medical device as defined in directive 93 42 eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. Directive 9879ec of the european parliament and of the council of 27 october 1998. The devices must be designed and manufactured in such a way that, when used under the conditions and for. 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 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. European commission enterprise and industry medical devices directive 93 42 eec short name. European commission enterprise and industry medical devices directive 9342eec short name. This applies for medical devices requiring the ce mark in europe. The completed forms and contracts as well as any other documents submitted by the. Pdf the european medical device regulation 2017745eu. 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. Commission implementing regulation eu no 92020 of 24.

B council directive 9342eec of 14 june 1993 concerning. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal. 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. 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, having regard to. These sections refer to requirements of 23 annex x of directive 93 42 eec and annex 7 of directive 90385 eec, respectively. European medical device directive essential requirements. Medical devices are products or equipment intended generally for a medical use. Forms templates further documents mdc medical device. 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 93 42 eec as well as additional services regarding the marketing of your medical devices within the european community.

Council directive 9342eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. They provide a practical support for the uniform application of these directives. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification. Mdr will replace the eus current medical device directive mdd 93 42 eec and active implantable medical devices directive 90 385 eec with a three year transitional period. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. Or download the pdf of the directive or of the official journal for free. Medical devices guidance document classification of medical. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating stable derivates of human blood or human plasma. Devices directive 9342eec and the directive for active implantable medical. Medical devices are classified on a riskbased system.

Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Commission implementing regulation eu no 92020 of 24 september 20 on the designation and the supervision of notified bodies under council directive 90385 eec on active implantable medical devices and council directive 93 42 eec on medical devicestext with eea relevance. Compliance with medical device directive 9842eec mdd. Read online b council directive 9342eec of 14 june 1993 concerning. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise. Here you can download documents, technical product manuals and graphic files. When considering the medical device, the criteria for risk acceptability is. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001.

Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Council directive 9342eec of 14 june 1993 concerning medical devices. Celab performs voluntary inspection activities on technical construction files to check their contents. This documentation demonstrates compliance with essential requirements annex i of the 9342eec. Medical devices internal market, industry, entrepreneurship. Note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. The eu medical device regulation was published on may 5, 2017. Note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on. Medical devices may only bear the ce marking if the essential requirements. New european regulation for medical devices to replace 93. 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. These sections refer to requirements of 23 annex x of directive 9342eec and annex 7 of directive 90385eec, respectively. Council directive 93 42 eec of 14 june 1993 concerning medical devices.

This document is available in either paper or pdf 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. Download b council directive 9342eec of 14 june 1993 concerning. These regulations make provision for a purpose mentioned in section 22 of the european communities act 1972 and it appears to the secretary of state that it is expedient for references to annexes 1 to 7 to directive 90385eec, annexes i to x to directive 9342eec, and. Medical device directive 9342eec cemarking qnet, llc. They are therefore of complementary nature to the general vademecum relating to the application of. These guidelines should be read in conjunction with the directive 90385 eec relating to active implantable medical devices and the directive 93 42 eec relating to medical devices.

The preferred document format is pdf files with bookmarks for ease of locating specific content. Graham clements page 2 of 6 introduction compliance of protective garments with the medical devices directive 93 42 eec or the personal protective equipment ppe directive 89686 eec was originally a choice between the two when the directives were first issued. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for. 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. Pdf the european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. Council directive 9342eec of 14th june 1993 on medical devices o. The classification rules of medical devices, as established in annex ix of directive 9342eec 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.