Product Active implantable medical devices
Scope of Directive 1990/385/CEE of 20/06/1990
Directive 2007/47/EC of 5 September 2007
Scope of application Applies to active implantable medical devices. The active medical device is connected for its operation to a source of electrical energy or to any other source of electrical energy or to any other source of energy other than that produced directly by the human body or by gravity. Active implantable medical device is any active medical device intended to be fully or partially implanted by surgical or medical intervention in the human body or by medical intervention in a natural orifice and intended to remain there after surgery
amending Council Directive 90/385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42 / EEC relating to medical devices, and Directive 98/8 / EC relating to placing on the market of biocidal products
Legislative Decree
Number:Legislative Decree. n. 507 of 14 December 1992
Title:Implementation of Directive 90/385 / EEC concerning the approximation of the laws of the Member States relating to active implantable medical devices.
Link:https://www.gazzettaufficiale.it/eli/id/1992/12/30/092G0529/sg

Number:Legislative Decree 25 January 2010, n. 37
Title:Implementation of directive 2007/47 / EC amending directives 90/385 / EEC for the approximation of the laws of the member states relating to active implantable medical devices, 93/42 / EC relating to medical devices and 98/8 / EC relating to placing on the market of biocidal products
Link:https://www.gazzettaufficiale.it/gunewsletter/dettaglio.jsp?service=1&datagu=2010-03-13&task=dettaglio&numgu=60&redaz=010G0053&tmstp=1268657917018
Ministerial Decree
Number:Ministry of Health Decree 20 February 2007
Title:Approval of the National Classification of Medical Devices (CND)
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2007-03-16&atto.codiceRedazionale=07A92230&elenco30giorni=false

Number:Ministry of Health Decree 20 February 2007
Title:New modalities for the formalities foreseen by article 13 of the legislative decree 24 February 1997, n. 46 and subsequent amendments and for the registration of active implantable devices as well as for the registration in the Directory of medical devices.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2007-03-16&atto.codiceRedazionale=07A92230&elenco30giorni=false

Number:Ministry of Health Decree 21 December 2009
Title:Amendments and additions to the decree of 20 February 2007 containing "New procedures for the requirements for the registration of active implantable devices, as well as for registration in the medical device directory
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2010-01-22&atto.codiceRedazionale=10A00596&elenco30giorni=false

Number:Ministry of Health Decree 25 June 2014
Title:Methods, procedures and conditions for conducting clinical investigations with active implantable medical devices pursuant to article 7, paragraph 6, of legislative decree no. 507 and subsequent amendments.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2014-09-19&atto.codiceRedazionale=14A07156&elenco30giorni=true

Number:Ministry of Health Decree of 13 March 2018
Title:Changes and updates to the national classification of medical devices (CND), as per the decree of 20 February 2007.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/eli/id/2018/05/21/18A03438/sg
Main Voluntary Technical Standards
Contatts
Altra AmministrazioneMinistry of Healthe.cecere@sanita.it
Altra AmministrazioneMinistry of Healthi.fontana@sanita.it
Keywords Active implantable medical devices