Article 11 and article 12a of council directive 9342eec of 14 june 1993 concerning medical devices, as amended by directive 200747ec of the european parliament and of the council of 5 september 2007, must be interpreted as meaning that software, of which at least one of the functions makes it possible to use patientspecific data for. The revision of the medical devices directive 9342eec. Due to its complexity, classification of standalone software will be covered in a specific. Class i medical devices are considered as low risk devices compared to other type of medical devices. The directive of june 14, 1993, required the passage of. Ce certification class i medical device ce marking. List european harmonized standards for the medical devices. 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. These sections are reproduced below for your information or. In that case, of importance are the medical device directives mdd. Council directive 9342eec of 14 june 1993 concerning medical devices.
Medical device software user interface language 9342 ce. Directive 9879ec of the european parliament and of the council of 27 october 1998. Any active medical device, whether used alone or in combination with. New links added in may 2019 software as medical device samd. There are lists of standards under each european directive e. Council directive 93 42 eec of 14 june 1993 concerning medical devices. During the transition period, manufacturers can place devices on the market under the currently applicable eu directives 93 42 eec, 9879ec and 90385 eec or under the new regulations if they fully comply with these. The medical device regulation of the european union. 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 9342eec.
One of the major requirements to prove conformity is the implementation of the quality management system according iso 9001 andor iso 485 and iso 14971. Council directive 9242eec of 21 may 1992 on efficiency. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Council directive 9242eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels subscriptions sign up to receive our reports print andor electronic and quarterly enewsletter.
B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Medical devices directive mdd 9342eec explained in the medical device directive m. The european union medical device regulation council regulation 2017745 of 5 april 2017 concerning medical devices, oj no l 1171 of 20170505 repeals the existing directives on medical devices. Council directive 9342eec contains the basic framework for the regulation of medical devices in the european union. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products. Directive 9342ecc was evaluated in the context of an impact assessment in 2012, resulting in a commission proposal on the revision of directive 9342eec. The regulation was published on 5 may 2017 and came into force on 25. Europe ce marking regulatory process for medical devices. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. The clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance. First guidance on new rules for certain medical devices. Reporting of changes to the notified body according to the directives substantial changes in the design and. 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.
Software, which drives a device or influences the use of a device, falls automatically in the same class. Directive 200070ec of the european parliament and of the. For all other classes, you will be audited each year by a notified body to ensure ongoing compliance with 9342eec or 90385eec. Eu electronic ifu instructions for use requirements. Because of the many types of devices covered by the mdd, the specific requirements depend on the. So if you want to meet the legal requirements in europe, the best standards to use for medical devices are listed under directive 9342eec at the europa website. Ec no 12232009 and repealing council directives 90385eec and 9342eec, will consolidate two existing legal provisions and replace both the current medical device directive 9342eec and the active implantable medical device directive 90385eec. Software as a medical device part ii in compliance magazine. Where a given product does not fall under the definition of medical device, or.
Regulation eu 2017746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic. Council directives 90385eec and 9342eec regulation eu 2017746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic medical devices and repealing directive 9879ec and commission decision 2010227eu guidance documents to the new regulations title 2. 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 90385 eec on active implantable medical devices aimdd 1990 council directive 93 42 eec on medical devices mdd 1993. Where postmarket clinical followup as part of the postmarket surveillance plan for the device is not deemed necessary, this must be duly justified and documented. European medical device directive essential requirements checklist pdf,160kb european medical device directive essential requirements. One of the most important aspects of the corrigendum certainly is that medical devices classified as class i under the medical devices directive 9342eec, mdd and upclassified under the mdr, will be exempt from mdr compliance. Benannte stelle nach richtlinie 9342ewg notified body. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. So 9342eec has been amended 5 times, by 9879ec, 200070ec, 2001104ec, 200332ec, and 200747ec.
European medical device directive essential 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. Like council directive 90385eec on active implantable medical devices aimdd2 and council directive 9342eec on medical devices mdd3 the ivd directive is based on the new approach and aims to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. According to directive 200747ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means. Luckily, there is a consolidated reprint of the medical device directive, issued in 2007, that consolidates the original text with these 5 amendments. Council directive 9342eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. Closed system loop fda recommended capa methodology october 11th, 2015 posted by posted by. Classification criteria definitions for the classification. The european unions proposed medical device regulation mdr will soon replace the eus medical device directive 9342eec and the directive on active implantable medical devices 90385eec, and is likely to result in important changes for medical device manufacturers. Conformity assessment route for the medical device directives 9342eec, 9879 ec and 90385eec.
Directive 200070ec of the european parliament and of the council of 16 november 2000. There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 9342eec as modified by 200747ec. Council directive 90385eec on active implantable medical devices aimdd 1990 council directive 9342eec on medical devices mdd 1993 council directive 9879ec on in vitro diagnostic medical devices ivdmd 1998 new regulations on 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. 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.
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. Council directive 93 42 eec of 14 june 1993 concerning medical devices direttiva 93 42 cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici oj l 169, 12. 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. Class 1 devices can be divided into three, a class 1 devices, b class 1 sterile devices, c class 1 measuring devices. With the upclassification of medical devices as per the new eu mdr. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years.
It is to be noted that to be qualified as an ivd medical device, stand alone software must first fulfil the definition of a medical device. The most technologically advanced solutions are not the state of the art. Medical device labeling in the european union mddi online. Failure to pass the audit will invalidate your ce marking certificate. The ivd directive was amended and corrected over time. Consolidated medical device directive 9342eec interactive web page. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Please find the latest consolidated ivdd 9879ec below. The conformity of medical devices and invitro diagnostic medical device according to european union directives 9342eec, 90385eec and 9879eec must be assessed before sale is permitted.
As per european mdd, nonsterile and nonmeasurable class i devices are exempted from notified body audit and certification. Recital 6 of directive 200747ec states that it is necessary to clarify that software in its own right, when specifically. Checklist for exporters of medical devices from australia to the european community essential requirements annex i, 9342eec as amended by directive 200747ec. 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. Software user interface is considered as labeling, and all rules for translations would apply as they would for an instruction for use. Then there were two more meddevs released in december, 2010 related to clinical study requirements in europe. Md 1111 software md 1106 active dental devices md 1108 active rehabilitation devices and active creation date. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Directive 9342eec on medical devices mdd, annex ii excluding 4 devices in class lla, llb or 111 no. The standards on these lists may be used by manufacturers to prove that their. Reporting of design changes and changes of the quality system.
Eu medical device directive 9342eec labelling requirements. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. Medical devices directive 9342eec and active implantable medical device directive 90385eec. If a medical device manufacturers software is classified as a medical device under directive 9342eec, then the software should be in the countrys official language. The two new regulations will come into full application in may 2020 for medical devices and may 2022 for in vitro diagnostic medical devices.
Reporting of design changes and changes of the quality system chapter. Specifically, there were four in december, 2009 and one in june, 2010. Medical device software under the eu mdr emma international. Since the 2007 amendment to the medical devices directive 9342ec1 aimed at clarifying its scope in relation to standalone software, there. B council directive 9342eec of 14 june 1993 concerning. Experts were right in assuming that the proposed document will be adopted unchanged with a very high probability. This, in turn, will boost confidence in our medical devices industry. If you are a manufacturer and you want to place your medical device on the eu market, you need to make sure it complies with the specific european directives set forth by the european commission. Directives 90385eec and 9342eec retrieved on 09052019 from. Medical devices within the eu are currently regulated by 3 directives. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Classification of medical devices and their routes to ce.
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