Product Medical devices
Scope of Directive 93/42/EEC of 14 June 1993
Scope of application The directive applies to medical devices and their accessories. Medical device means any instrument, apparatus, plant, substance or other product, used alone or in combination (including the computer software used for correct functioning) and intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention , control, therapy or alleviation of a disease; to diagnose, monitor, treat, alleviate or compensate for an injury or handicap; study, replacement or modification of anatomy or of a physiological process; intervention on conception, which product does not exert the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.
Legislative Decree
Number:Legislative Decree n. 46 of February 24, 1997
Title:Implementation of Directive 93/42 / EEC concerning medical devices.
Link:https://www.gazzettaufficiale.it/eli/gu/1997/03/06/54/so/49/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 23 July 1998
Title:Provisions relating to the eyewear trade in implementation of Article 20 of Legislative Decree No. 46/1997
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=1998-08-04&atto.codiceRedazionale=098A6989&elenco30giorni=false

Number:Ministry of Health Decree 3 February 2003
Title:Guide to correct use of contact lenses, warnings, precautions and risks associated with use
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2003-03-18&atto.codiceRedazionale=03A03285&elenco30giorni=false

Number:Ministry of Health Decree 2 August 2005
Title:Method of submitting documentation for notification of clinical investigation with medical devices
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2005-09-09&atto.codiceRedazionale=05A08760&elenco30giorni=false

Number:Ministry of Health Decree 15 November 2005
Title:Approval of the forms for reporting incidents or near misses, involving medical devices and in vitro diagnostic medical devices.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2005-11-24&atto.codiceRedazionale=05A11039

Number:Ministry of Health Decree of 23 February 2006
Title:Advertising 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=2006-04-21&atto.codiceRedazionale=06A03894&elenco30giorni=false

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:Law no.86 of 5 June 2012
Title:Establishment of the national register and regional registers of breast prosthetic implants, information obligations to patients, as well as prohibition of breast plastic surgery for minors.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/gunewsletter/dettaglio.jsp?service=1&datagu=2012-06-27&task=dettaglio&numgu=148&redaz=012G0106&tmstp=1341215505954

Number:Ministry of Health Decree 8 February 2013
Title:Criteria for the composition and functioning of ethics committees.
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/eli/id/2013/04/24/13A03474/sg

Number:D.P.C.M. March 3, 2017
Title:Identification of surveillance systems and records of mortality, cancer and other pathologies
Scope of application:
Any technical standard indicated in the DM:
Link:https://www.gazzettaufficiale.it/eli/id/2017/05/12/17A03142/sg

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 Medical devices