Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. An understanding of iec 62304 will help you meet software development requirements for 21cfr part 820 as well as the medical device directive 9342eec. Through transposition into the national legislation of the member states, persons and companies are subject to the requirements of the european directives. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. On 5 april 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. 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 9342eec of 14 june 1993 concerning medical devices. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Compliance of medical devices with the new requirements according to article 2 of directive 9342eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if. Medical devices are products or equipment intended generally for a medical use.
Whereas the major part of medical devices are covered by council directive 90385eec of 20 june 1990 on the approximation of laws relating to active implantable medical devices 2 and council directive 9342eec of 14 june 1993 concerning medical devices 3 with the exclusion of in vitro diagnostic medical devices. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Council directive 9342 eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. This highly revealing interactive course lays out the principal sections of the medical device directive 9341eec and. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. For the purposes of this directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. To enable your organization to achieve ce marking certification sgs is notified body 0120 under directive 9342eec for all devices including drug device combinations and associated directives 200332ec animal tissue, 200550ec total joint implants and 200747ec amendments. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs eu law. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices.
Council directive 93 42 eec on medical devices mdd 1993 council directive 9879ec on in vitro diagnostic medical devices ivdmd 1998 new regulations on medical devices. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the. They entered into force on 25 may 2017 and will progressively. Council directive 9315eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses. Questions relating to the implementation of directive 200747 ec 1. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing.
Council directive 9342eec 2 quality system dentaurum implants 206, kb council directive 9342eec 5 quality system dentaurum implants 200. The ce marking directive 9368eec ce marking association. The mdr replaces the medical device directive 9342eec and the active implantable medical devices directive 90385eec, the ivdr replaces the ivd directive 9879ec. Council directive 93eec of 5 april 1993 on unfair terms.
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. Medical devices directive 9342ec evaluation and testing. Electronic instructions for use for medical devices in the. Council directive 9342eec of 14 june 1993 concerning. B council directive 9343eec of 14 june 1993 on the. Download notice follow this document table of contents hide table of contents. Medical devices directive 93 42 eec pdf download 10yi83. Council directive 93eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. 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. Directive 9368eec amending directives 89392eec machinery atex directives. Council directive 93 42 eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. Apr 12, 2011 article 8, of council directive 9342eec, a.
Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. Through transposition into the national legislation of the member states, persons and companies are subject. The new medical device regulation will enter into force after a threeyear transition period ending on may 25, 2020. Medical devices internal market, industry, entrepreneurship. Jan 23, 2014 an understanding of iec 62304 will help you meet software development requirements for 21cfr part 820 as well as the medical device directive 93 42 eec. Application of the classification rules shall be governed by the intended purpose of the devices. 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. In vitro diagnostic medical devices directive 9879ec. Labeling requirements for medical devices in europe youtube. F2 labs can perform the emc and safety testing that is required by the medical device directive for. Bsi training european medical devices directive requirements.
B council directive 9342eec of 14 june 1993 concerning. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. Why the revision of the medical devices directive 9342eec mdd was necessary and what the regulators have looked at changing. If the device is intended to be used in combination with another device, the. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Council directive 9343eec on the hygiene of foodstuffs. Medical device directive 9342eec certification service. 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 by the manufacturer. Council directive 9343eec of 14 june 1993 on the hygiene. Council directive 9342eec on medical devices mdd 1993 council directive 9879ec on in vitro diagnostic medical devices ivdmd 1998 new regulations on medical devices. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device.
The mdr replaces the medical device directive 93 42 eec and the active implantable medical devices directive 90385 eec, the ivdr replaces the ivd directive 9879ec. New european regulation for medical devices to replace 93. Council directive 9342eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385eec and 9342eec with respect to. Fda consultants medical device consultants pharmaceutical. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to. Council directive 93 42 eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Council directive 93 98 eec of 29 october 1993 harmonizing the term of protection of and certain related rights. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular articles 57 2, 66 and 100a thereof. 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 medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Council directive 93 42 eec of 14 june 1993 concerning medical devices.
Classification criteria definitions for the classification rules. Council directive 9343eec of 14 june 1993 on the hygiene of. Ce marking and european medical device directive 9342cee. A european directive can be regarded as an european law, and unlike its name may assume is legally binding for every member state of the european union. B council directive 9343eec of 14 june 1993 on the hygiene. Ce marking and european medical device directive 93 42 cee. On april 5, 2017, the eu adopted the new medical device regulation, replacing the two existing directives, the medical devices directive and the active implantable medical devices directive. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. In vitro diagnostic medical devices directive 9879ec tuv. 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. The european unions council directive 9342eec concerning medical devices contains the essential requirements to be met by medical device manufacturers in order to market their products in the 28 member countries. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. 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 93 eec of 5 april 1993 on unfair terms in consumer contracts official journal l 095, 21041993 p. Classification criteria definitions for the classification. The revision of the medical devices directive 9342eec. Directive 2006116ec of the european parliament and of the council of 12 december 2006 on the term of protection of and certain related rights codified version is the consolidated version of 93 98ec with amendments that is in force since 2007. Understanding the medical devices directive 9342 eec 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. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 9342eec last amended by directive 200747ec annex i, section 7. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Download council directive 9342eec on medical devices mdd. Medical device directive archives medtech intelligence. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. Mdi consultants is an fda consulting company for the medical device, pharmaceutical and food industries on fda quality assurance, regulatory compliance and clinical issues for us and eu compliance. Ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives. Council directive 93 42 eec of 14 june 1993 concerning medical devices eu law.
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. The medical device regulation mdr replaces both, the medical device directive mdd, 9342eec and the directive for active implantable. New eu medical device regulations are set to replace the. Understanding the medical devices directive 9342 eec directive 9342eec 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. Council directive 9342eec of 14 june 1993 concerning medical devices eu law. New european regulation for medical devices to replace 9342. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 93 42 eec concerning medical devices. The medical device directive council directive 93 42 eec 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. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs the council of the european communities, having regard to the treaty establishing the european economic community and in particular article 100a thereof, having regard to the proposal from the commission, in cooperation with the european parliament 1.
Council directive 9398eec of 29 october 1993 harmonising the term of protection of and certain related rights is a european union directive in the field of eu law, made under the internal market provisions of the treaty of rome. Industry specific proficiency tuv sud product service has industry specific know how on medical products and testing and certification in accordance with directive for active implantable medical devices 90385eec aimd, directive on medical devices 9342eec mdd, and directive on in vitro diagnostic medical devices 9879ec ivdd. 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. This document is available in either paper or pdf format. Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 93 42 eec last amended by directive 200747ec annex i, section 7. Download more information regarding the process for changes in the certification status. In contrast to directives, regulations are directly applicable and do not need to be transposed into national law, lowering the risks of discrepancies in interpretation across.
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