Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. The result was the european economic community eec, created in 1958. Regulation eu 2017745 also known as the medical devices regulation mdr has been adopted on may 25, 2017 and will replace the medical devices directive 9342eec mdd and active implantable medical devices directive 90385eec aimdd. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Certificates issued by notified bodies in accordance with directives 90385eec and 9342eec prior to 25 may 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with annex 4 to directive 90385eec or annex iv to directive 9342eec which shall become void at the latest.
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. 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. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. F1 substituted 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.
Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. Annex of the directive, conformity assessment procedure, ec certificate. 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 revision of the medical devices directive 9342eec. Basic information about the european directive 9342eec. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.
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. I have had benefit from reading several threads, downloading attachments in the elsmar forums. Whats changed compared to the mdd the new eu medical device regulation eu mdr is not radically different from the current medical device directive mdd. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Certificates issued by notified bodies in accordance with directives 90385 eec and 93 42 eec prior to 25 may 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with annex 4 to directive 90385 eec or annex iv to directive 93 42 eec which shall become void at the latest. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1. Council directive 90385eec on active implantable medical devices aimdd 1990 council. Mdr medical devices regulation eu 2017745 mdi europa. 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. Aug, 2019 whats changed compared to the mdd the new eu medical device regulation eu mdr is not radically different from the current medical device directive mdd. European medical device directive essential requirements.
Medical devices within the eu are currently regulated by 3 directives. The council of the european communities, having regard to the treaty establishing the european economic community, and in. 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. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. In this respect, it is not important whether a device has been produced within the eu or imported from any country outside the eu. 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. The new mdr medical device regulation 2017745 is set to replace the existing national requirements of the medical device directive mdd 9342eec within a specified time frame. 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. Bsi training european medical devices directive requirements. 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. The medical device regulation mdr 2017745 will replace the eus current medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. Thats not to underestimate the amount of work that will be required to switch from the current mdd to the new eu mdr. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing.
Medical devices 9342cee and active implantable medical. Understanding the machinery directive 2006 42ec the directive has been put in place because. The medical device directive 9342eec 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. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices.
Council directive 9343eec of 14 june 1993 on the hygiene of. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Medical device directive mdd 9342eec as modified by 200747ec. 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. Medical device directive mdd 93 42 eec as modified by 200747ec. 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 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. The social cost of the large number of accidents caused by the use of machinery can be reduced by. Further information on the revision of the medical device regulation can also be found on the eu website. Conformity with medical device directive 9342eec is mandatory all devices that fit the definition of a. The directives 90385ewg aimd and 9342ec mdd have been changed by directive 200747ec of the european parliament and the council of 5 september 2007. European medical device directive essential requirements checklist. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. For devices falling under directive 93 42 eec other than custommade devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules see articles 9 and 11 of directive 93 42 eec. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. The medical device regulation mdr 2017745 will replace the eu s current medical device directive 93 42 eec and the eu s directive on active implantable medical devices 90385 eec.
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. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs eu law. Council directive 9343eec on the hygiene of foodstuffs. Council directive 90385 eec on active implantable medical devices aimdd 1990 council directive 93 42 eec on medical devices mdd 1993. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and.
These sections are reproduced below for your information or. There is a transition period of 3 years making the regulation fully applicable on may 26, 2020. 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. You must comply with medical devices directive 9342eec requirements before you can market your medical device in the eu. Therefore i am attaching the pdfs to this posting for anyone who is. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2.
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. Manufacturers have the duration of the transition period to update their technical documentation and. Provisions of directive 200747ec directive 200747ec amends directive 90385 eec on active implantable medical devices and directive 93 42 eec on medical devices. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. This, in turn, will boost confidence in our medical devices industry. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. 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 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. I have created a new pdf version from the eu mdd 9342eec for use on mobile devices. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Medical devices internal market, industry, entrepreneurship. Eu medical device directive 9342eec labelling requirements.
The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes. 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. As you are probably aware, eu directive 200747ec modifies the medical devices and active. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy.
Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a. 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. Medical devices directive 93 42 eec pdf download 10yi83. Medical devices directive 9342eec mdd and subsequent amendments. Medical device directive 9342eec cemarking qnet, llc.
June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. 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. For devices falling under directive 9342eec other than custommade devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules see articles 9 and 11 of directive 9342eec. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs. F1 substituted 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. 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. 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.
Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. Council directive 9343eec of 14 june 1993 on the hygiene. Bsis european medical devices directive requirements course is designed to provide a top level overview of the guidelines of the european medical device directives mdd 9342eec and comprehensive information on the mdd 200747 changes. 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. Medical devices directive 9342eec pdf download 10yi83. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Directive 9879ec of the european parliament and of the council of 27 october 1998. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. Directive 9879ec of the european parliament and of the council of.
Ce marking directive 9342eec as amended available in the download. The devices must be designed, manufactured and packed in such a way that their characteristics and. Medical devices mdd 9342cee and active implantable medical devices. Council directive 9342eec of 14 june 1993 concerning 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. Council directive 9342eec of 14 june 1993 concerning. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22.
B council directive 9342eec of 14 june 1993 concerning. Because of the many types of devices covered by the mdd, the specific requirements depend on. 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. 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 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.
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