Dec 15, 2015 the european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease. 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 tothe treatyestablishing the european economic community, andin particulararticle 100a. The article 12 of mdd 93 42 eec medical device directive describes the requirements particularly for procedure for systems and procedure packs, and procedure for sterilization conformity assessment. Article 12 is all about declarations and compliance with annex ii ec. Registry number of the report on the examination of the design dossier. Duration transient normally intended for continuous use for less than 60 minutes. Eu regulation of medical device systems and procedure. Guidance document classification of medical devices. If the appliance is at the same time a medical device within the meaning of directive 9342eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of. Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status.
The european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease. Article 12 particular procedure for systems and procedure packs and procedure for sterilisation 15. Rule all devices incorporating, as an integral part, a substance which, if used. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Both the medical device directive 93 42 eec and the active implantable medical devices directive 90385 eec have been modified by a new directive 200747ce. Relationship of iso 485, medical device directive, and ce marking. The medical device directive is intended to harmonise the laws relating to medical devices.
Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Guidelines relating to the demarcation between directives 90385 eec, 93 42 eec and 6565 eec. Confirmation of conformity must be based on clinical data. Medical device directive mdd 93 42 eec as modified by 200747ec. Jun 22, 2012 in article 2 of directive 84539eec, the following subparagraph is added to paragraph 1.
Eu regulation of medical device systems and procedure packs. 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. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. M1 council directive 93 42 eec of 14 june 1993 l 169 1 12. 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. Classification criteria definitions for the classification.
Under the terms of the medical device directive a competent authority is nominated by the government. Eu medical device directive 9342eec labelling requirements. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. The other terms are defined in chapter i section 1 of annex ix of directive 93 42 eec. The medical device regulation mdr 2017745 will replace the eus current medical device directive 93 42 eec and the eus directive on active implantable medical devices 90385 eec. 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. Mds g7 guidance on criteria of medical devices bundling.
Council directive 9342eec medical device regulation. Iso 485 how to use it to get the medical device ce mark. 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. Intended purpose is defined in article 1 paragraph 2g of directive 93 42 eec. How to use iso 485 to get your devices approved for ce marking. From 26 may 2020, any publication of a notification in respect of a notified body in accordance with directives 90385 eec and 93 42 eec shall become void.
Directive 9342eec, in article 12, regulates the particular conformity assessment needed to configure individual medical devices into a system or procedure pack. 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. Combination of cemarked and noncemarked medical devices and nonmedical devices chapter. Manufacturers have the duration of the transition period to update their technical documentation and. This certificate is valid only together with ec certificate according to directive. Ce marking in medical devices, 9342at, 200747ec szutest. Article 12 is all about declarations and compliance with annex ii ec declaration of conformity full quality assurance system and annex v ec. European national states must translate this directive into national law. Article 12 of the medical devices directive mdd 9342eec defines the conformity assessment necessary to configure individual medical. The medical device directive council directive 93 42 eec of 14 june 1993 concerning medical devices, oj no l 1691 of 199307 12 is intended to harmonise the laws relating to medical devices within the european union. Apr 12, 2011 article 8, of council directive 9342eec, a. Directive 90385 eec aimdd active implantable medical devices directive check free resources major european regulations.
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. Basic information about the european directive 9342eec on. Particular procedure for systems and procedure packs and procedure for sterilisation. The european medical device directive or 93 42 eec regulates which medical devices may be sold in the european market, while 21 cfr 820 is an fda quality systems regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company organization in order to ensure that their manufacturing processes and the resultant products. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. 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. By way of derogation from article 11 this article shall apply to systems and procedure packs. The clinical evaluation and its documentation must be actively updated. Directive 90385eec aimdd active implantable medical. Directive 89391eec of 12 june 1989 on the introduction of measures to. Contents of technical documentation for mdd 9342eec and. Medical device directive sterilization, mdd article 12. You are at liberty to handle your device as a normal medical device, and there are no special requirements that im aware of for normal devices that contain components that are already ce marked in their own right even if theyre also medical devices in their own right. The third directive is the in vitro diagnostics directive 9879ec.
R, ec rep, european authorized representative, authorized representative, ec or ce representative. Click on the arrow on the right corner to scroll up. The social cost of the large number of accidents caused by the use of machinery can be reduced by. F1 particular procedure for systems and procedure packs and procedure for sterilisation 1.
European medical device directive essential requirements checklist. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. European medical device directive essential requirements. The eu representative is mandatory for noneuropean manufacturers wishing to sell medical devices and invitro diagnostic devices ivds on the eiropean market eu authorized representative is known by multiple names such as e. Medical devices directive 9342eec european commission. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. All classes of medical devices will require clinical data. Medical devices guidance document classification of medical. Medical device directive mdd including amendments, the latest being directive 200747ec. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.
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 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. Article 12 is all about declarations and compliance with annex ii ec declaration of conformity full quality assurance system and annex v ec declaration. The number indicates the year of initial release 1993 and the consecutive number of directives in that year. Council directive 9342eec of 14 june 1993 concerning. 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. Particular procedure for systems and procedure packs. 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.
B council directive 9342eec of 14 june 1993 concerning. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Mdd article 14 registration of persons responsible for placing devices on the market. Ce marking ce mark for active implantable 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. Article 12 covers the declarations and compliance with annex ii full quality assurance system and annex v production quality assurance. This document is meant purely as a documentation tool and the. Mar 30, 2011 article 12, of council directive 9342eec, a. Understanding the machinery directive 2006 42ec the directive has been put in place because. Classification, indicating the rule bullet point according to annex ix of directive 93 42 eec statement as to whether the ingredients of the product include a substance as defined in annex i section 7. In reference to the recent changes to the mdd 93 42 eec by its amendment the 200747ec, the following needs to be brought to your attention.
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 machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. However, a fundamental revision of those directives is needed to establish a robust. The present meddev is part of a set of guidelines relating to questions of application of eu directives on medical devices. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. These sections are reproduced below for your information or. Posts tagged council directive 93 42 eec massimop z annex 17 xvii correlation table annex, annex xvii, article, correlation table, council directive 90385 eec, council directive 93 42 eec, mdr. The manufacturers guide to the revised mdd 1 introduction the longanticipated revisions to the medical device directive mdd 93 42 eec and the directive for active implantable devices 90385 eec were published in the. Article 12 of the medical devices directive mdd 93 42 eec defines the conformity assessment necessary to configure individual medical devices into a system and to ensure safety when putting these systems into service and during use. The schedules you have selected contains over 200 provisions and might. 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. Article 123 of the regulation states that any natural or legal person. Medical devices directive 93 42 eec mdd and subsequent amendments.
Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. Medical device directive archives medtech intelligence. Medical device directive 9342 ewg mdd the mdd is the medical device directive or 93 42 eec. Bsi training european medical devices directive requirements. When any legal entity puts together medical devices each bearing its own ce mark, the assembly is referred to as a system or a procedure pack. Medical devices guidance document classification of. Medical device directive sterilization, mdd article 12 particular procedure for systems and procedure packs and procedure for sterilisation medical devices directive explained how medical devices are regulated in europe 1. The directives 90385ewg aimd and 93 42 ec mdd have been changed by directive 200747ec of the european parliament and the council of 5 september 2007. Use the following index to navigate into the different sections of the directive. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Because of the many types of devices covered by the mdd, the specific requirements depend on.
If packs, sets or kits do not have conformity assessment under article 12 of eu mdd 93 42 eec, they may be bundledgrouped as single medical device see section 1. Medical device directive mdd 9342eec as amended by 2007 42 ec pavan kumar malwade 01 april 2016 1 2. The commission shall, no later than 5 september 2010, submit a report to the european. The schedules you have selected contains over 200 provisions and might take some time to download. Medical devices directive 93 42 eec pdf download 10yi83. Medical devices internal market, industry, entrepreneurship. New european regulation for medical devices to replace 93.
Mdd article 12 labeling requirements for ce marked medical. Classification criteria definitions for the classification rules. European mdd directive 93 42 eec requirement for the registration of responsible persons when placing a medical device onto the european market. As most of these laws directly refer back to the directive, the. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Council directive 9342eec of 14 june 1993 concerning medical devices. The revision of the medical devices directive 9342eec.
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