For a device to be classified as an active implant, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. Directive 200965ec of the european parliament and of the. This directive makes new provisions on marine equipment and revokes directive 9698ec on that subject. It applies to all sectors of activity, both public and private, except for specific public service activities, such as the armed forces, the police or certain civil protection services. Council directive 90 385 eec 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. Directive 90 385 eec aimdd active implantable medical devices directive consolidated version. Council directive 75440eec of 16 june 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the member states. Direttiva 90 385 cee del consiglio, del 20 giugno 1990, per il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi medici impiantabili attivi. Council directive 75440eec european environment agency.
Commission directive 90128eec of 23 february 1990 relating. Conform to europes medical devices directives among europes three medical device directives. Objectivethis directive lays down minimum requirements for personal protective equipment ppe used by workers at work. Council directive 9342eec of 14 june 1993 concerning medical devices, last amended by directive 200747ec. There are three medical device directives in place, the directive of active implantable medical devices 90 385 eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. Eu parliament and council passed a directive making certain proposed amendments to the pd. Legislative texts directive 201490eu emsa european. Reporting of design changes and changes of the quality system page 59 andor the requirements of the directive e. Ce marking, directive 90 385 eec preexisting national legislation national legislation transposing emc. For the purposes of this directive, the following definitions shall apply. The definition of what constitutes a manufacturer is identical.
Commission of the european communities brussels, november 2003 comments concerning certain articles of the regulation ec no 16062002 of the european parliament and of the council of 19 july 2002 on the application of international accounting standards and the fourth council directive 78660eec of 25 july 1978 and the. Directive 90 385 cee du conseil, du 20 juin 1990, concernant le rapprochement des legislations des etats membres relatives aux dispositifs medicaux implantables actifs. Frequently asked questions about european mtn programs. Despite the fact that the ce mark has been around for more than 15 years, its meaning and importance are often not well.
Whereas council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 3 is the first case of application of the new approach to the field of medical devices. Pdf on sep 7, 2001, matthias rauterberg and others published the eu directive 90270 on vduwork. The ce marking directive 9368eec ce marking association. In november 2015, as part of the cmu action plan, the european commission published a legislative. Text with eea relevance legislative texts directive 2014 90 eu emsa european maritime safety agency. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90 385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal. Active implantable medical devices directive ce marking. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec 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. The active implantable medical devices directive with the official reference number 90 385 eec applies only to active implantable devices. This directive shall apply to active implantable medical devices. The avo inspections must be conducted inside and outside of each active process building, around all. Directiva consiliului din 20 iunie 1990 privind apropierea legisla.
Active implantable medical device directive 90 385 eec. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices fi r l of cial jou na l 189, 20071990 p. Directive 90385cee dispositifs medicaux implantables actifs. Active implantable medical devices directive 90 385 eec. Council directive 9342eec of 14 june 1993 concerning medical devices. Products which combine a medicinal product or substance and a medical. Active implantable medical devices directive 90385eec. Council directive 90496eec on nutrition labelling for foods in order to bring the provisions on nutrition labelling into line with consumer needs and expectations action n66, the white paper indeed identifies nutrition labelling as an important tool in helping consumers make informed dietary choices, adapted to their individual needs. 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. Eu medical device directives 90385eec active implantable medical. It does not provide a systematic treatment of all provisions of the directive, but instead deals only with those of the directives elements of which experience has shown that further clarification was needed. Council directive of june 1990 on package travel, package holidays and package tours 90314eec 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.
Ce marking ce mark for active implantable medical devices. This document is meant purely as a documentation tool and the. Use of work equipment directive 2009104ec concerns the minimum health and safety requirements for the use of work equipment by workers at work it places obligations on businesses and employers to take into account potential dangers to operators and other persons using or affected by machines and equipment. Commission directive 90 128eec of 23 february 1990 relating to plastic materials and articles intended to come into contact with foodstuffs official journal l 075, 21031990 pp. This document is meant purely as a documentation tool and. Recital 6 of directive 200747ec states that it is necessary to clarify that software in its own right. Directive october 31, 2017 from epa administrator scott. Ce marking is currently required for many products sold in europe, yet many u. Directive 90 385 eec on active implantable medical devices custom made devices and devices all other devices manuchoice choice ec declaration of conformity to type production quality assurance. The term ec mark or ce mark appeared in this directive is out of date and has been officially replaced by term ce marking in 1993 in the ce marking directive 9368eec. No 12232009 and repealing council directives 90385eec and 9342eec. Reporting of design changes and changes of the quality system. Council directive 90314eec of june 1990 on package. Note the present guidelines are part of a set of guidelines relating to questions of application of ec directives on medical devices.
Directive 89656eec use of personal protective equipment. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices in force oj. However overtime the directive is now fairly redundant as all of the directives mentioned have either been superseded or amended to include the ce marking requirement along with the details of affixing the ce mark itself. Aimd 0101 active implantable medical devices for ec declaration of conformity complete quality assurance system annex 2 annex 5 annex 3 creation date. If the device is intended for use in combination with other devices or. Frequently asked questions about ce marking or questions that ought to be asked more frequently by. Active implantable medical devices internal market.
Combination of ce marked and non ce marked medical devices and nonmedical devices chapter. Ulpami communication systems use frequency bands shared with other services. Policy directive 21 provision of library services page 2 of 2 4. The amending directive the amending directive has entered into force and was required to be implemented by member states by 1 july 2012. Directive 90 385 eec aimdd active implantable medical devices directive check free resources major european regulations. Definitionsdefinition of the term personal protective equipment. Implementation, transitional provisions article 23. Directive 89391eec osh framework directive sicurezza. The active implantable medical device aimd directive 90 385 eec defines an active implantable medical device as any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Description directive legislation text harmonised standards. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices oj l 189, 20. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, last amended by directive 200747ec. Regulations for active implantable medical devices aimd under the eu directive 90 385 eec an active implantable medical device aimd is any active medical device that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes, and.
Contentspersonal protective equipment must be used when the risks cannot be avoided or sufficiently limited by technical means of collective protection or procedures of work organization. The guidelines have been carefully drafted through a process of intensive consultation of the. Directive 90496cee du conseil, du 24 septembre 1990. Commission regulation 7222012 concerning active implantable medical. Directive 9368eec ce marking directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90 385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec. Pdf directive 200747ec1 amends the earlier medical device and active. Directive 90385cee du conseil, du 20 juin 1990, concernant le rapprochement des legislations des etats membres relatives aux dispositifs medicaux. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec oj l189 of 20 july 1990 this consolidated text has been prepared by commission services on the basis of the above directives amending directive 90 385 eec. In conclusion the ce marking directive was responsible for the requirements of attaching a ce mark to product. Council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec. In general, they are computer based tools which combine medical knowledge. Ce marking of premdd devices page 27 vdtuevdocument dn.
Decision in respect of refusal or restriction article 20. Use the following index to navigate into the different sections of the directive. Full page photo print food safety authority of ireland. Le conseil des communautes europeennes, dispositions necessaires pour satisfaire les exigences essen tielles. Council directive 93 42eec of 14 june 1993 concerning medical devices 3 with the exclusion of in vitro diagnostic medical devices. Directive 90 385 eec aimdd active implantable medical devices directive pdf check free resources major european regulations. Pdf clinical evaluations clinical investigations under the amended.
Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020 date of application to meet the requirements of the mdr. Directive october 31, 2017 from epa administrator scott pruitt, strengthening and improving membership on epa federal advisory committees. Technical documentation and medical device regulation bsi. Frequently asked questions about ce marking or questions. Flowchart of ca procedures as provided by the directives. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. Objectivethe aim of this directive is to introduce measures to encourage improvements in the safety and health of workers at work.
Directive 90219eec council directive 90219eec of 23 april 1990 on the contained use of genetically modified microorganisms oj no l 117 of 8. B council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec oj l 189, 20. Requirements for hydrocarbon emission controls and gas conservation in the peace river area. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90 385 eec. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90 385 eec oj l 189, 20. Directives 90 385 eec and 9342eec medical devices clinical evaluation report presentation guide the elements of the clinical evaluation report are records of the process that the manufacturer applies to the identification, selection, appraisal and critical analysis of clinical data in order to meet the. Commission communication in the framework of the implementation of council directive 90 385 eec on the approximation of the laws of the member states relating to active implantable medical devices publication of titles and references of har monised standards under union har monisation legislation. Since 1978 mdiconsultants have been providing clients highquality and highvalue consulting services such as. Provisions of directive 200747ec directive 200747ec amends directive 90 385 eec on active implantable medical devices and directive 9342eec on medical devices. Council directive 90 385 eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices this document comes with our free notification service, good for the life of the document. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Directive 90385eec aimdd active implantable medical.
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