The Directive: AIMDD 90/385/EEC

AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which 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” additionally the directive requires that all active implantable medical device manufacturers must affix CE-Marking to the Directive in order to place their devices on the European Market. The AIMDD 90/385/ EEC also mentions the language requirement issue in Article 4.4, “when a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex I to be in their national language(s).”

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in Active Implantable Medical Devices Directive

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