Directive 9342eec for medical devices by enterprise europe. 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. It outlines the process for classifying medical devices and explains how to seek clarification on classification of a medical device. The regulatory gods in the eu like their ce marking of conformity just as the mark is depicted in annex xii. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. 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.
To determine which class your device belongs to, consult format pdf. They provide a practical support for the uniform application of these directives. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. 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. On friday 27 april 2012, the european commission published updated lists of the european harmonized standards that pertain to the medical devices directive 9342ec, in vitro diagnostics directive 9879ec, and the active implantable medical devices directive 90385eec. Classification of medical devices european commission europa eu. 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 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. 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. This document is meant purely as a documentation tool and. This document is a guide for classifying medical devices covered by the european directive 9342eec the directive, as amended and the related irish regulation, s.
Directive 90385eec covering active implantable medical devices modified by. Council directive 93 42 eec of 14 june 1993 concerning medical devices. The en 1041 normally sold as bs en 1041, the official english language edition is the european requirement for information supplied by the manufacturer of medical devices. The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes. Medical devices directive 9342ec evaluation and testing. This manual is written and compiled in accordance with the council directive 9342eec for mdd medical devices and harmonized standards. Ds best advice is to abide by the annex and leave perfection alone. 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 9342eec european commission. 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. 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. 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. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision.
Eu medical device directive 9342eec labelling requirements. Council directive 9342eec of 14 june 1993 concerning. Classification criteria definitions for the classification. This document is available in either paper or pdf format. Europa enterprise guidelines on the implications of the. Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of iso 485. Council directive 9342eec archives medtech intelligence. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. 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. Directive whereas certain medical devices are intended to administer medicinal products within the. The revision of the medical devices directive 9342eec. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Freezer certified as a medical device according to directive 9342eec.
The guidelines deal with specific issues in the context of the aforementioned. Bs en 1041 information supplied by the manufacturer of medical devices. 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. 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. New european regulation for medical devices to replace 93. Equipped with a microprocessor and large 7 digital display, ideal for longterm storage at ver. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. M5 stand alone software is considered to be an active medical device. This applies for medical devices requiring the ce mark in europe.
The mdr will replace the current eus medical device directive 9342eec and the. Medical device directive 9342eec cemarking qnet, llc. Jan 12, 2012 directive 9342eec for medical devices. The active implantable medical devices directive 90396 eec schoenmakers, c. 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. 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. Council directive 9342eec of 14 june 1993 concerning medical devices. 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. 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. What links here related changes upload file special pages permanent link. When considering the medical device, the criteria for risk acceptability is.
Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. Directive 9342eec for medical devices by enterprise. This manual is written and compiled in accordance with the. Essential requirements annex i, 9342eec as compliance. Medinfo medinfo council directive 9342eec on medical devices. 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. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. 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. Medical devices directive 93 42 ec evaluation and testing manufacturers must comply with the medical device directive, mdd 93 42 eec, in order to sell their medical products into europe. New european regulation for medical devices to replace 9342. A guide for manufacturers and notified bodies under directives 9342eec and 90385eec note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. Delivered inhouse, this 1day practical workshop provides an awareness of the european directive 93 42 eec concerning medical devices.
Compliance with medical device directive 9842eec mdd. Overview a medical device is defined in directive 93 42 eec as. List european harmonized standards for the medical devices. The active implantable medical devices directive 90396eec schoenmakers, c. Understanding the european directive 9342eec for medical. The medical device directive is intended to harmonise the laws relating to medical devices.
This directive shall apply to medical devices and their accessories. 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. B council directive 9342eec of 14 june 1993 concerning. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 93 42 eec annex ix. Both the medical devices directive 93 42 eec and in vitro diagnostic medical device directive 9879ec require manufacturers or, their authorised representatives or others placing medical devices on the eea market, to provide certain information to the competent authorities in the eea member state where they have a registered place of. 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. Europa enterprise guidelines on the implications of. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive.
Harmonized european standards, available for a fee. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. How are medical devices regulated in the european union. Both the medical devices directive 9342eec and in vitro diagnostic medical device directive 9879ec require manufacturers or, their authorised representatives or others placing medical devices on the eea market, to provide certain information to the competent authorities in the eea member state where they have a registered place of. Directive 9342eec on medical devices mdd, annex ii excluding 4 devices in class lla, llb or 111 no. Oct 03, 2011 annex xii ce marking of conformity of the medical device directive is all about the mark, the whole mark, and nothing but the mark. The content of this page deals only with the medical devices directive 93 42 eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Council directive 9342eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385eec and 9342eec with respect to. Medical device directive document centers standards forum. European medical device directive essential requirements. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Classification criteria definitions for the classification rules.
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. 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 paragraphs 8. Medical devices directive 93 42 eec try it for free on. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. 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 devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in article 1 2 a, as specified by the manufacturer. The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. Annex xii ce marking of conformity of the medical device directive is all about the mark, the whole mark, and nothing but the mark. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. 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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. At the end of the course, you will be able to implement the requirements of the directive and to audit organizations against it.
Medical device directive 93 42 eec mdd annex i essential requirements medical devices directive explained how medical devices are regulated in europe i. Classification, indicating the rule bullet point according to annex ix of directive 93 42 eec together with a brief rationale for this classification, and reasons why particular rules do not apply, if this is not selfevident where not selfevident, the manufacturer should document the rationale for classifying as a medical device. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. These sections are reproduced below for your information or.
These guidelines should be read in conjunction with the directive 90385eec relating to active implantable medical devices and the directive 9342eec relating to medical devices. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. Directives 90385eec and 9342eec medical devices clinical. Ce marking of medical devices, classification lne gmed, notified. Details of the mdd 93 42 eec directive essential requirements. Delivered inhouse, this 1day practical workshop provides an awareness of the european directive 9342eec concerning medical devices. 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. Medical device directive archives document centers. Directive 9879ec of the european parliament and of the council of 27 october 1998.
For the medical device directives 90385eec, 9342ec, 9879ec and. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 9342eec annex ix. Because of the many types of devices covered by the mdd, the specific requirements depend on. Medical devices directive mdd 9342eec explained in the medical device directive m.
The directive 93 42 eec on medical devices mdd 93 42, is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices. Directiveeec directive, directive devices markingthe. F2 labs can perform the emc and safety testing that is required by the medical device directive for. In case of modifications and software upgrades, the information contained in this document is subject to change without notice. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. May 27, 2011 when medical device companies do business in europe, they are required to conform to the eus medical device directive, 9342eec one important way to comply is to use the applicable standards from the harmonised list for medical devices.
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