Product In vitro diagnostic medical devices
Scope of directive 98/79/EC of 27 October 1998
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.
Legislative Decree
Number:Legislative Decree n. 332 of 08/09/2000
Title:Implementation of Directive 98/79 / EC relating to in vitro diagnostic medical devices
Link:https://www.gazzettaufficiale.it/eli/gu/2000/11/17/269/so/189/sg/pdf
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 of in vitro diagnostic medical devices
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/eli/gu/2014/05/06/103/sg/pdf

Number:DM 12 April 2012
Title:Provisions on the import and export of human blood and its products.
Scope of application:This decree regulates the import and export of human blood and its products, including those intended for the production of in vitro diagnostic medical devices
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2012-06-26&atto.codiceRedazionale=12A07181&elenco30giorni=false
Main Voluntary Technical Standards
Contatts
Altra AmministrazioneMinistry of Healtha.colliardo@sanita.it
Keywords