Eu medical device regulation mdr 2017745 wo tuv rheinland. Download council directive 9342eec on medical devices mdd. New european regulation for medical devices to replace 9342. Medical devices guidance document classification of medical. Only one name is allowed and is to be preceded by the eu symbol for manufacturer. The directives 90385ewg aimd and 9342ec mdd have been changed by directive 200747ec of the european parliament and the council of 5 september 2007. Sg4n33r16 regulatory audit reports 90385eec 2007 active implantable medical device directive leave a reply cancel reply your email address will not be published. The essential requirements of the medical device directive 9342 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. In order to ensure that conformity assessment under the medical device directive functions effectively, manufacturers should be able to determine the. Directive 200070ec of the european parliament and of the council of 16 november 2000. Provisions of directive 200747ec directive 200747ec amends directive 90385eec on active implantable medical devices and directive 9342eec on 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.
Note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. The mdr, which replaces the medical devices directive 93 42 eec and active implantable medical devices directive 90385 eec, has a transition period of three years. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Medical device directive mdd or 9342eec as a first step, you need to verify whether your products falls within the definition of a medical device in accordance with article 1 paragraph 2a of directive 9342eec. New european regulation for medical devices to replace 93. 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. Medical devices directive 9342eec mdd and subsequent amendments. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385 eec and 93 42 eec text with eea relevance. Medical device directive 9342eec cemarking qnet, llc.
They can be used not only as applications but also as guidelines and checklists, helping you through the complex process of application for, say, a conformity assessment procedure in accordance with directive 9342eec. Right click on the link below to download to your computer select save target as. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Directive 9342eec concerning medical devices 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. By way of derogation from directives 90385eec and 9342eec, devices which comply with this regulation may be placed on the market prior to 26 may 2020. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Medical devices directive 9342eec medical electrical equipment characteristics of digital xray imaging devices part.
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. European national states must translate this directive into national law. Medical device directive mdd gives the essential requirements that are applicable for instruments, apparatus, appliances, materials or other articles used by. Guidance document classification of medical devices. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1. 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. This document contains compliance information for wireless lan products which are intended to be placed on the market within the european union, lichtenstein, switzerland, iceland, norway, turkey and other countries that have implemented the eu directive 19995ec andor eu 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. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Regardless of the class a device belongs to, the manufacturer is obliged to prepare a technical file for the respective device or device family. Medizinprodukterichtlinie 9342ewg medical device directive mdd. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. 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. Download declaration in word or pdf format, with your logo.
The number indicates the year of initial release 1993 and the consecutive number of directives in that year. Medical devices internal market, industry, entrepreneurship. 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. However, we will continue to support existing mdd certification until the end of their validity period or may 25, 2024, at the latest through specific mdd surveillance audits. The european medical devices regulation 2017745 mdr came into force on may 25, 2017 and will replace the two directives 9342eec mdd and 90385 eec aimdd by may 26, 2020. 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. Eu medical device directive 9342eec labelling requirements. Class i devices with low risk such as external patient support products. Understanding the medical devices directive 9342 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. This document contains compliance information for wireless lan products which are intended to be placed on the market within the european union, lichtenstein, switzerland, iceland, norway, turkey and other countries that have implemented the eu directive 19995ec andor eu directive 9342eec. The guidelines have been carefully drafted through a process of intensive consultation of the.
I have had benefit from reading several threads, downloading attachments in the elsmar forums. By way of derogation from directives 90385 eec and 93 42 eec, conformity assessment bodies which comply with this regulation may be designated and notified prior 26 may 2020. I have created a new pdf version from the eu mdd 93 42 eec for use on mobile devices. Because of the many types of devices covered by the mdd, the specific requirements depend on the. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. 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 mdd 93 42 eec. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european. By way of derogation from directives 90385eec and 9342eec, conformity assessment bodies which comply with this regulation may be designated and notified prior 26 may 2020. 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. Information supplied by the manufacturer of medical devices format. 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. Download notice follow this document table of contents hide table of contents. Questionnaires and application forms for medical devices.
Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. Reference the classification rules in annex ix of the mdd to determine your device class. Duration transient normally intended for continuous use for less than 60 minutes. Ce marking in medical devices, 9342at, 200747ec szutest. Conformity with medical device directive 9342eec is mandatory all devices. Medical devices directive 9342eec pdf download 10yi83. Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status. Having regard tothe treatyestablishing the european economic. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 9342eec and the active implantable medical devices directive aimdd 90385eec. European medical device directive essential requirements.
Before you can market your medical device in the eu, your product must meet the essential requirements in annex 1 of the medical devices directive mdd, as well as the standards related to your device type. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and. Sg4n33r16 regulatory audit reports 90385 eec 2007 active implantable medical device directive leave a reply cancel reply your email address will not be published. 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. Mdd richtlinie 9342ewg medizinprodukterichtlinie deutsch. Oct 11, 2007 sg4n33r16 regulatory audit reports 90385 eec 2007 active implantable medical device directive leave a reply cancel reply your email address will not be published. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. 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.
Directive 200747ec guidance document for mdd 9342eec. Because of the many types of devices covered by the mdd, the. European mdd directive 93 42 eec requirement for the registration of responsible persons when placing a medical device onto the european market. European medical devices regulation mdr 2017745 update. As a result, sgs will guide its customers through the process of transferring their certificates from mdd 9342eec to the new regulation. 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. Ce marking of medical devices mdd 9342eec tuv sud canada. Medical devices directive 93 42 eec pdf download 10yi83. The devices must be designed, manufactured and packed in such a way that their characteristics and. Basic information about the european directive 9342eec. 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. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. 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.
Please find the latest consolidated mdd9342 eec below, with the biggest change in 2007 which came into force in. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. I have created a new pdf version from the eu mdd 9342eec for use on mobile devices. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products. Provisions of directive 200747ec directive 200747ec amends directive 90385 eec on active implantable medical devices and directive 93 42 eec on medical devices. These sections are reproduced below for your information or. Details of the mdd 9342eec directive essential requirements.
The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Starting immediately, you may submit your application for mdr certification. B council directive 9342eec of 14 june 1993 concerning. In laymans terms, the design dossier is the technical documentation plus a. 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. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. The medical device directive is intended to harmonise the laws relating to medical devices. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 93 42 eec and the active implantable medical devices directive aimdd 90385 eec. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Therefore i am attaching the pdfs to this posting for anyone who is. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. Classification criteria definitions for the classification rules. Medical device directive 9342 ewg mdd the mdd is the medical device directive or 9342eec.
Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. By way of derogation from directives 90385 eec and 93 42 eec, devices which comply with this regulation may be placed on the market prior to 26 may 2020. 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. 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.
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 93 42 eec of 14 june 1993 concerning medical devices. 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. European union 2 the eu is a unique economic and political partnership between 28 european countries that. Or download the pdf of the directive or of the official journal for free. B 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. Details of the mdd 93 42 eec directive essential requirements. For products classified with medium to high degree of risk class is, im, iia, iib and iii the medical device directive requires a conformity assessment procedure involving a notified body.
Before you can market your medical device in the eu, your product must meet the essential requirements in annex 1 of the medical devices directive mdd, as well as the standards related to your device type reference the classification rules in annex ix of the mdd to determine your device class. This european standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and in certain situations viceversa during surgical procedures in operating theatres and other medical settings with similar requirements. Medical devices guidance document classification of. Understanding the medical devices directive 9342 eec 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 european medical devices regulation 2017745 mdr came into force on may 25, 2017 and will replace the two directives 93 42 eec mdd and 90385 eec aimdd by may 26, 2020.
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