European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Changes to iso485 mdd and ivd directives white paper 1 of 5 according to the international organisation for standardisation iso, this international standard is intended to facilitate global alignment of appropriate regulatory requirements for. The devices must be designed and manufactured in such a way that, when used under the. In order to avoid delays or interruption in the supply of medical devices as of 21 march 2010, manufacturers notably of a new type of medical device, devices that change their class due to the revised classification rules or.
We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf. Medical device directive 9342eec tuv sud america tuv sud. Mdd annex x clinical evaluation medical devices directive explained how medical devices are regulated in europe medical device validation. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Essential requirements checklist mdd 9342 eec background of annex x section 1. Medical device directive 9342eec cemarking qnet, llc.
Medical devices directive mdd 9342eec o new medical device regulation mdr just released compliance required within the next 3. The new mdr provides an additional time after the date of application allowing to place new products under the mdd for max. 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 directive 9342eec mdd and subsequent amendments. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Download council directive 9342eec on medical devices mdd. The medical device directive 9342eec 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.
Download this free pdf medical device classification form to make this process easier. Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. Mdd the medical devices directive product assurance by.
Information and training presentation general provisions. Ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec text with eea relevance. As regards the transitional regime of directive 200747ec see the interpretative document of the commissions services of 5 june 2009. Before the new mdr regulation came into force, the md directive mdd meant that medical device manufacturers could come up with their own internal methods of compliance if they followed any of the meddevs andor en iso norms, which caused inconsistencies and safety issues amongst manufacturers. These service terms shall govern the medical devices directive and in vitro diagnostic devices directive notified body services to be performed by the ul contracting party as identified.
Pdf the new european medical device regulation 2017745. How are medical devices regulated in the european union. What follows is based on the presenters personal and qts collective knowledge regarding eu mdr,udi and eudamed requirements. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of article 1 of directive 200183ec 6, that device shall be governed by this directive, without prejudice to the provisions of directive 200183ec with regard to.
Meddev guidance list download medical device regulation. Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. 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. 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. 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. In europe, following the recent medical device directive changes medical device reporting mdr 2017745. New medical device directive 2018 outline of medicare. Sg4n33r16 regulatory audit reports 90385eec 2007 active implantable. Products within the scope of mdd article 1 of the directive defines a medical device to mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used. From may 26th 2020 the medical device directive will not be valid anymore. 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 90385eec aimdd active implantable medical. Before you can market your medical device in the eu, your product must meet the essential requirements in annex 1 of the medical devices directive mdd, as well as the standards related to your device type reference the classification rules in annex ix of the mdd to determine your device class. 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 falling under the medical device directive mdd.
This free of charge application was designed to help manufacturers, consultants, notified. Medical device regulatory profile for india international trade. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Take under control list of products, declarations of conformity, amended declarations of conformity. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Get the right standards form the list of harmonised standards. Learn how to classify medical devices in europe with our free medical device classification eu form pdf. As of this time the medical device regulation mdr will be the new regulatory framework which will be applicable for all medical devices placed on the market in the eu. Collectively known as the medical device directive mdd, this core legal framework consists of three directives that regulate the safety and marketing of. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. Medical devices directive 9342eec pdf download 10yi83. B council directive 9342eec of 14 june 1993 concerning.
Council directive 9342eec of 14 june 1993 concerning medical devices. Download from the link below the mdr in the main european languages. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. 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. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. Download declaration in word or pdf format, with your logo. The regulation of medical devices in the european union. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12.
European medical device directive essential requirements. The medical device directive is intended to harmonise the laws relating to medical devices within 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 text with eea relevance. Download mdr free mdr gap analysis mddmdr resources. The mdr also strongly affects distributors and importers.
Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices oj no l 189 of 20 july 1990. New european regulations for medical devices anvisa. Manufacturers have the duration of the transition period to update their technical documentation and. Council directive 9342eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. Whereas certain medical devices are intended to administer medicinal products within the meaning of council directive 6565eec of 26. Active implantable medical devices internal market.
Medical devices directive 9342eec try it for free on. Although india has a growing domestic medical device manufacturing sector the country still imports more. Not with the mdd 9342ec classification rules but the new one. More information about the transition can be found here. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. 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 free circulation of medical devices within the eu also applied in iceland, liechtenstein, norway, switzerland. Some of these newly inscope products do not even have medical applications. Regulation ec no 12232009 of the european parliament and of the council 2. Directive 200070ec of the european parliament and of the council of 16 november 2000. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.
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