Product |
In vitro diagnostic medical devices |
Rev. |
16/09/2021 |
Scope of |
directive 98/79/EC of 27 October 1998
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Scope of application |
This Directive applies to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories are considered to be full-fledged in vitro diagnostic medical devices.
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Legislative Decree |
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Ministerial Decree |
Number: | DM 23 December 2013 |
Title: | New procedures for the registration of in vitro diagnostic medical devices in the Directory of medical devices and for the requirements relating to the registration of manufacturers and authorized representatives of in vitro diagnostic medical devices. |
Scope of application: | definition of the procedures for registration in the Directory of medical devices |
Any technical standard indicated in the DM: | |
Link: | https://www.gazzettaufficiale.it/eli/gu/2014/05/06/103/sg/pdf |
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Main Voluntary Technical Standards |
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Contatts |
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Keywords |
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