B council directive 9342eec of 14 june 1993 concerning. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Socialdiabetes helps you to control better your diabetes treatment with the convenience of carrying your logs directly on your smartphone. Transitional periods mdr, mdr, transition, regulatory requirements. Active implantable medical devices internal market. Directive 200070ec of the european parliament and of the. Medical devices internal market, industry, entrepreneurship and. Richtlinie 9342ewg sanner deutschland downloadnewsimg download. Juni 1993 uber medizinprodukte zur fussnote 1 zur fussnote 2 zur fussnote 3 abl. Kavo dental turbines the perfect interplay of hand and tool. Page title class views daily average edits editors size protection watchers links.
The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90385eec. Richtlinie 93 42 ewg anhang il des rates liber medizinprodukte vom 14. Unite 42 is a belgian television series written by julie bertrand, annie carels and charlotte joulia. 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. Type 1 and type 2 diabetes care requires a lot of tracking. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.
Abkurzungsverzeichnis 90385 ewg siehe aimd 9342 ewg siehe mdd 9879eg siehe ivdd aimd aktives implantierbares medizinisches gerat aimdd europaische richtlinie uber aktive implantierbare medizinische gerate, 90385 ewg alarp as low as reasonable possible selection from basiswissen medizinische software, 2nd edition book. Here you can find certificates of our company and products in five languages available for download. In accordance with the last date of validity of the ec certificate of conformity as issued by the abovementioned. The references published under directive 9342eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj.
Council directive 93 42 eec of 14 june 1993 concerning medical devices. The medical device regulation mdr replaces both, the medical device directive mdd, 9342eec and the directive for active implantable. Certified ink according to eg regulations 93 42 ewg, anhang 1. This highly revealing interactive course lays out the principal sections of the medical device directive 9341eec and. Council directive 9342eec of 14 june 1993 concerning medical devices. You can choose from the wide range of kavos top class dental turbines. Otto bock cbrace instructions for use manual pdf download. Cochlear wireless phone clip user manual pdf download. Mdd richtlinie 9342ewg medizinprodukterichtlinie deutsch. The references published under directive 93 42 eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to.
Richtlinie 9342 ewg des rates uber medizinprodukte vom 14. For complex medical devices risk analysis is sometimes required to be in compliance with iso14971 and or mdd 93 42 eec medical device directive for the european economic community. This product has been classified as a class i device according to the classification criteria out. Wireless phone clip automobile accessories pdf manual download.
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. The amendments are being done either by including those into other directives, for example in the invitrodiagnostic medical device directive, or by means of a separate document which covers a specific aspect, for example, the directive 200070ec of the european parliament and the council of november 16, 2000, amending council directive 93 42. 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. View and download cochlear wireless phone clip user manual online. Download more information regarding the process for changes in the certification status.
Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Accuchek bolusvorschlag zur berechnung ihrer insulindosis sofern verfugbar, aktivierung durch einen arzt. En 46001 2 translation from german into english pons. 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 unit 42 original title. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Thomas weber cqo, director quality and regulatory affairs. Each kavo dental turbine is the result of extensive ergonomic and anatomical studies with consistent dimensions, angles and contours for balanced handling. Medical devices internal market, industry, entrepreneurship. Meet our medical director and dental clinic team berlinklinik. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system.
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