Medical devices directive 9342eec requirements for. We also provide notified body services for the following related. How medical devices are currently regulated within the eu. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. The european union eu medical device regulation mdr is due to take full effect in may 2020, and its new scope includes a large number of products and devices that were outside the scope of the eu medical device directive mdd.
The new medical device regulation adopted by eu, replacing the two existing directives, the medical devices directive mdd and the active implantable medical devices directive. Preparation of a technical file or design dossier essential requirements. Click here to download a pdf version of the invitro diagnostic devices directive 9879ec directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices introduction introduction article 1 scope, definitions article 2 placing on the market and putting into service article 3 essential requirements article 4 free movement. As a bis formerly the dti notified body under the medical device directive, we provide the testing needed to achieve certification, assistance with the compilation of a technical file, and support for ongoing quality testing. Compliance with the revised directive became mandatory on 21 march 2010. The new european medical devices regulation mdr eu 2017745 will legally apply from may 26, 2020, and sgs, like all other notified bodies, will no longer be authorized to deliver ce certificates under the medical devices directive mdd. European medical device directive essential requirements.
Table of contents european medical device regulation. Increasing risk class iii medical devices in vitro diagnostic medical devices class iib class iia class i class d class c class b class a notified body approval required. Jan 26, 2018 the new europe eu medical device regulations mdr published by the european commission on may 5, 2017 revamped major portions of the eu medical device directive mdd, raising compliance bars for all device manufacturers, economic operators and notified bodies. Essential requirements are part of the technical file or design dossier. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. How the new eu medical device regulation will disrupt and. Mdr tool is an easy solution to implement the new medical. Council of the european union, interinstitutional file. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Directive 90385eec on active implantable medical devices. The current european union eu regulatory framework governing medical devices includes council directive 90385eec on active implantable medical devices and council directive 9342eec on medical devices. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. Significant changes ahead for medical device manufacturers.
Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. To set up manufacturing processes to maintain this level of performance and safety. Recital 6 of directive 200747ec states that it is necessary to clarify that software in its. Commissions services shall guide a uniform practice throughout the eu. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens.
Council directive 9342eec of 14 june 1993 concerning medical devices. Table of contents european medical device regulation 2017745. European commission on the basis of the medical devices directive mdd 1. It will supersede the current medical device directive, 9342ec, following a threeyear transition period. By complying with the essential requirements of the eus mdd and other regulations that apply to medical devices, manufacturers can tap into the european. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017. 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. To keep up with advances in science and technology, 2 new european regulations are replacing 3 existing directives in the years up to 2022. 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. How to put a medical device on the european market. 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 the european parliament and the council of the european union. New eu mdr regulations and revamp of the medical device. Medical device directive mdd 9342eec as modified by 200747ec.
The directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has. Similarities and differences by elisabethann wright and steven datlof reproduced with the kind permission of global regulatory press from the journal of medical device regulation, 2010, 73, 1422. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of directive65 65eec withregard tothemedicinal. Medical devices internal market, industry, entrepreneurship. If you are a manufacturer, authorised representative, importer or distributor of medical devices in the eu, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply. The european union is making major changes to the medical device. Medical devices guidance document classification of. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. The medical device regulation mdr has entered into force on may 26th 2017. You need to demonstrate that your medical device meets the requirements in the medical devices directive.
New eu mdr regulations and revamp of the medical device directive. Guidance leaflet for products without an intended medical purpose pdf. The medical devices directive mdd applies to all general medical devices not covered by the active implantable medical devices directive or the in vitro diagnostic medical devices directive. 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. Regulation ec no 12232009 of the european parliament and of the council 2. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation. The european union medical device regulation of 2017. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles. Agreement has finally been reached over the new european union medical device regulation mdr and is expected to come into effect in june 2017. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. European medical devices regulation mdr 2017745 update. Medical device technical file and design dossier for eu ce. 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. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020.
The manufacturer should first decide if the product concerned is a medical device as defined in directive 9342eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. In practice, this means that all new devices, their manufacturers and other stakeholders in the field must meet the requirements of the mdr from may 26, 2020. As the name suggests, it is a regulation and no longer a directive and all medical. Medical device directive 9342eec cemarking qnet, llc. If you are manufacturing a medical device, you must meet new. Pdf the european medical device regulation 2017745eu. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Meddev guidance list download medical device regulation. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. To meet the new eu medical device regulation objective, organizations will need to take a structured and wellmanaged approach over the next coming years depending on. Device specific vigilance guidance dsvg template dsvg 00 dsvg 01 dsvg 02 new mir form as from january 2019 mancano 2 file. The regulation of medical devices in the european union.
Important requirements for medical devices design medical device directive, essential requirement 2 1. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. As you are aware, the european medical device industry will undergo significant change as a result of the new medical device regulation which is currently finalised since may 26th, 2017. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 9342eec as regards medical devices incorporating stable derivates of human blood or human plasma. Since directive 200747ec is addressed to the member states, preliminary transposition into national.
All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 9342eec annex ix. The updated version replaces an earlier version of meddev 2. The medical device directive is intended to harmonise the laws relating to medical devices within the european union. In response to er 4 please provide information about the defined product lifetime not shelf life. The current eu medical device and in vitro diagnostic medical device directives mdd and ivdd do not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity inhouse use. On 15 july 2016, the european commission updated meddev 2. B council directive 9342eec of 14 june 1993 concerning. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. How the eu medical device regulation changes ce marking. Guideline for authorised representatives european commission. European legislation ensures the safety and efficacy of medical devices and facilitates patients access to devices in the european market. Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of.
European medical device regulation 2017745 the following 175 pages were published in the official journal of the european union on 5 may 2017. The qualification of software, either as a device or an. Mdd the medical devices directive product assurance by. Medical devices are products or equipment intended generally for a medical use. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the.
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. How are medical devices regulated in the european union. The new european mdr and ivdr regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans. Collectively known as the medical device directive mdd, this core legal framework consists of three directives that regulate the safety and marketing of medical devices in europe and came into effect in the 1990s. The new europe eu medical device regulations mdr published by the european commission on may 5, 2017 revamped major portions of the eu medical device directive mdd, raising compliance bars for all device manufacturers, economic operators and notified bodies. Pdf the european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. The machinery, product, assembly or subassembly covered by this declaration of conformity must not be put into service until the machinery into which it is to be incorporated has been declared in conformity with the provisions of the applicable directives. Placing on the market of fully refurbished medical devices chapter.
Medical devices within the eu are currently regulated by 3 directives. An introductory guide to the medical device regulation mdr and the in vitro diagnostic medical device regulation ivdr. Mdr was approved by the european parliament on april 5, 2017 and was published in the official journal of the european union on 5th may 2017. In vitro diagnostic medical devices are governed by directive 9879ec. The importance of implementing a continuous cycle of. Requirement 4 of mdd 9342eec definitions of lifetime. Regul ation eu 2017745 of the european parliament and of the council of 5 apr il 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. 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. An introductory guide to the medical device regulation.
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