Consolidated medical device directive 9342eec interactive web page. These regulations contain the legislative measures necessary for the implementation of three european community directives. Eu medical device directive revision continued medical. How medical devices are currently regulated within the eu. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020. Medical devices directive 9342ec evaluation and testing manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products.
The devices must be designed and manufactured in such a way that, when used under the. New european regulation for medical devices to replace 9342. The european medical device regulati on 2017745 mdr 1 passed the european parliament. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Directive 90385eec on active implantable medical devices directive 9342eec on medical devices directive 9879ec on in vitro diagnostic medical devices ivds same rules applied for the whole eu transposed into national legislation. 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.
Directive 9879ec of the european parliament and of the council of. Same rules applied for the whole eu transposed into. Navigating the new european union medical device regulations. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Cen, cenelec or etsi the reference of the standard and its related directive is published in the official journal series of the eu annex z of the standard details the essential requirements of the directive that are covered 17. In june 1998, the directive became mandatory and medical devices, which fell under the scope of the medical device directive, were no longer allowed without the ce mark on the.
European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 5 of 22 manufacturer. This study examined the impact of this directive on the competitiveness of u. Regulation of medical devices in europe the role of. Directive 200070ec of the european parliament and of the council of 16 november 2000. Aug 04, 2015 according to a report from emergo, the first 50 pages of the new list which also covers nonmedical device industry products refers to both new and supersededamended standards under the eus medical devices directive, in vitro diagnostics directive, and active implantable medical device directive. The regulation of medical devices in the european union. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001.
European medical device directive essential requirements. Impact of eu medical device directive on medical device software. The fiveyear transition period has passed since the implementation of the medical devices directive, and products must meet its essential requirements before they can earn the ce mark and be sold in the eu market. Standalone software is regarded as driving or influencing the use of a device and so falls. Hpra guide to classification of a medical device 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. Medical device directive 9342eec cemarking qnet llc. The new european union medical devices regulation deloitte uk. Jan 27, 2015 the ce marking also means that the product can be freely marketed anywhere in the eu 27 member states of the eu and efta countries, iceland, norway and liechtenstein. 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 implementing measures for directives. For example, under the new directive, products that are classified as accessories could now be covered under the definition of a medical device. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. European medical device directives the medical device directives is a new approach directive relating to the safety and performance of medical devices which were harmonized in the eu in the 1990s.
Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. L 1172 en official jour nal of the european union 5. B 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 text with eea relevance oj l 117, 5. Pdf the european medical device regulation 2017745eu. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive.
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 harmonized eu standards. When determining the classification of medical devices under the eu directives, it is necessary to clearly understand a range of definitions related to medical devices as defined by the eu under the applicable device directives. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. The new european medical device regulation mdr has been published in the official journal of the european union. The medical device directive 9342eec the active implantable medical device directive 90385eec the in vitro diagnostic devices directive 9879ec the radio and telecommunications terminal equipment directive 995ec directives include. Medical devices directive testing mdd 9342eec f2 labs. Medical devices within the eu are currently regulated by 3 directives. For a manufacturer to legally place a medical device on the european market the requirements of the directive have to be met and a ce mark applied. Preparing for conformity assessment application for ce marking of medical devices duration.
New european regulation for medical devices to replace 9342eec and 90385. Eu medical device directive eu mdd governing medical. Currently, the eu regulatory framework consists of the medical device directive 9242eec, the active implantable medical directive 90385eec 5, the in vitro. Compliance with the revised directive became mandatory on 21 march 2010.
B council directive 9342eec of 14 june 1993 concerning. The medical device directive is intended to harmonise the laws relating to medical devices within the european union. Directive whereas certain medical devices are intended to administer medicinal products within. As already noted, a key update to the eu definition in the medical device directives was the inclusion of software, when specifically intended for medical uses, in the formal definition. Download from the link below the mdr in the main european languages. Conformity with medical device directive 9342eec is mandatory all. Medical device labeling in the european union mddi online. 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. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. Directive 9879ec of the european parliament and of the council of 27 october 1998. 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 directive.
Medical devices are products or equipment intended generally for a medical use and are regulated at member state level. Medical devices internal market, industry, entrepreneurship. Council directive 9342eec of 14 june 1993 concerning medical devices. This guidance provides information on the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr.
The medical devices and the invitro diagnostic devices regulations have introduced new responsibilities for the european medicines agency ema and national competent authorities in the assessment of certain categories of medical device. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Having regard tothe treatyestablishing the european. Directive 90385eec on active implantable medical devices directive 9342eec on medical devices new regulation on medical devices directive 9879ec on in vitro diagnostic medical devices new regulation on in vitro diagnostic medical devices revision of the eu medical devices law from eu directive to eu regulation 18. Sep 27, 2014 eu medical device directive revision continued posted on september 27, 2014 by annet muetstege visscher last week glenis willmott was announced to be the new rapporteur for the medical device directive revision. The mdd is supplemented by an older directive on active implantable medical. Medical devices directive 9342eec european commission. The mdr entered into force on 25 may 2017, marking the start of the transition period for manufacturers selling medical devices into europe. How medical devices are regulated in europe eu commission transition guidance on directive 200747ec. References made to the medical device directives include the council. Upcoming revisions to the regulatory framework within the eu will affect the ability for a medical device manufacturer to legally sell a medical device in the european market.
The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. Directive 9879ec on in vitro diagnostic medical devices ivds. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purposes of. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Medical devices are regulated in the european union by three ec directives. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.
142 137 1218 925 378 605 1352 1218 1586 246 627 799 1223 1286 869 131 40 85 883 644 449 1291 878 400 1360 1289 83 1012 390 138 122 39 523 1585 666 501 1261 687 1434 1388 559 643 774 279 1245 715 251 365