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. Eu medical device directive 9342eec labelling requirements. Bsi training european medical devices directive requirements. 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. There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 9342eec as modified by 200747ec. Medical device software user interface language 9342 ce. Consolidated medical device directive 9342eec interactive web page. Any active medical device, whether used alone or in combination with. Regulation eu 2017746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic. Software as a medical device part ii in compliance magazine. Ce certification class i medical device ce marking. 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.
Council directive 9342eec contains the basic framework for the regulation of medical devices in the european union. Reporting of design changes and changes of the quality system chapter. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Council directive 9342eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p.
Medical devices directive 9342eec and active implantable medical device directive 90385eec. Experts were right in assuming that the proposed document will be adopted unchanged with a very high probability. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. European medical device directive essential requirements checklist pdf,160kb european medical device directive essential requirements. 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. 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. Directive 200070ec of the european parliament and of the council of 16 november 2000. Due to its complexity, classification of standalone software will be covered in a specific. With the upclassification of medical devices as per the new eu mdr.
Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. B council directive 9342eec of 14 june 1993 concerning. Invitro diagnostic devices directive 9879ec directive 9879ec on in vitro diagnostic medical devices interactive web. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Council directive 9242eec of 21 may 1992 on efficiency. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products. The ivd directive was amended and corrected over time. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. 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. The medical device regulation of the european union. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Checklist for exporters of medical devices from australia to the european community essential requirements annex i, 9342eec as amended by directive 200747ec. List european harmonized standards for the medical devices.
Eu electronic ifu instructions for use requirements. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Directives 90385eec and 9342eec retrieved on 09052019 from. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. The revision of the medical devices directive 9342eec. Directive 9342ecc was evaluated in the context of an impact assessment in 2012, resulting in a commission proposal on the revision of directive 9342eec. 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 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. European medical device directive essential requirements. Medical devices directive mdd 9342eec explained in the medical device directive m. Specifically, there were four in december, 2009 and one in june, 2010.
Where a given product does not fall under the definition of medical device, or. The standards on these lists may be used by manufacturers to prove that their. 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. First guidance on new rules for certain medical devices. 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 lists of standards under each european directive e. 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. For all other classes, you will be audited each year by a notified body to ensure ongoing compliance with 9342eec or 90385eec. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. Directive 200070ec of the european parliament and of the. Classification criteria definitions for the classification. 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. 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. The latter is known as software as a medical device samd sometimes called standalone medical device software.
Council directive 90385 eec on active implantable medical devices aimdd 1990 council directive 93 42 eec on medical devices mdd 1993. Contents of technical documentation for mdd 9342eec. Reporting of changes to the notified body according to the directives substantial changes in the design and. 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. 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. Council directive 9342eec of 14 june 1993 concerning medical devices.
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. Classification of medical devices and their routes to ce. Directive 9342eec on medical devices mdd, annex ii excluding 4 devices in class lla, llb or 111 no. 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. The most technologically advanced solutions are not the state of the art. The directive of june 14, 1993, required the passage of. 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.
Then there were two more meddevs released in december, 2010 related to clinical study requirements in europe. 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. New links added in may 2019 software as medical device samd. 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. 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. Luckily, there is a consolidated reprint of the medical device directive, issued in 2007, that consolidates the original text with these 5 amendments. Benannte stelle nach richtlinie 9342ewg notified body. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.
Software user interface is considered as labeling, and all rules for translations would apply as they would for an instruction for use. Medical device software under the eu mdr emma international. These sections are reproduced below for your information or. This, in turn, will boost confidence in our medical devices industry. Md 1111 software md 1106 active dental devices md 1108 active rehabilitation devices and active creation date. Software, which drives a device or influences the use of a device, falls automatically in the same class. Please find the latest consolidated ivdd 9879ec below. 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. 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. So 9342eec has been amended 5 times, by 9879ec, 200070ec, 2001104ec, 200332ec, and 200747ec. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing.
The clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance. Class 1 devices can be divided into three, a class 1 devices, b class 1 sterile devices, c class 1 measuring devices. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Since the 2007 amendment to the medical devices directive 9342ec1 aimed at clarifying its scope in relation to standalone software, there. In that case, of importance are the medical device directives mdd. Europe ce marking regulatory process for medical devices.
The two new regulations will come into full application in may 2020 for medical devices and may 2022 for in vitro diagnostic medical devices. 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. Class i medical devices are considered as low risk devices compared to other type of medical devices. Closed system loop fda recommended capa methodology october 11th, 2015 posted by posted by. Reporting of design changes and changes of the quality system page 49 2. Reporting of design changes and changes of the quality system. 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. 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. Medical devices within the eu are currently regulated by 3 directives. Directive 9879ec of the european parliament and of the council of 27 october 1998. 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. The regulation was published on 5 may 2017 and came into force on 25. 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.