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Medical Device Legislation

The European Directives are transposed into national laws in the different member states. In Italy the AIMD, MDD and IVD Directives have been transposed into the following national laws:

  • Transposition of the AIMDD Directive Decreto Legislativo n. 507 - 14 dicembre 1992
  • Transposition of the MD Directive Decreto Legislativo n. 46 - 24 febbraio 1997
  • Transposition of the IVD Directive Decreto Legislativo n. 332 - 8 settembre 2000

Legislative Decree no. 37 of 25 January 2010, transposing Directive 2007/47/EEC, has brought some important modifications and integrations to L.D. 46/97 on medical devices, L.D. 507/92 on active implantables and Article 19 of L.D. 332/00 on in vitro diagnostics.

MEDICAL DEVICE LEGISLATION  - D.L. n. 507 - 14 dicembre 1992

Transposition of the AIMDD Directive - Classification of Medical Device, EC Declaration of Conformity, CE Marking

Decreto Legislativo n. 507 - 14 dicembre 1992

"Attuazione della direttiva 90/385/CEE concernente il ravvicinamento delle legislazioni degli Stati membri relative ai dispositivi medici impiantabili attivi"

MEDICAL DEVICE LEGISLATION - D.L. n. 507 - 14 dicembre 1992

Transposition of the MD Directive - Classification of Medical Device, EC Declaration of Conformity, CE Marking

Decreto Legislativo n. 46 - 24 febbraio 1997

"Attuazione della Direttiva 93/42/CEE concernente i Dispositivi Medici"

MEDICAL DEVICE LEGISLATION - D.L. n. 46 - 24 febbraio 1997

Transposition of the IVD Directive - Classification of in Vitro Medical Device, EC Declaration of Conformity, CE Marking

Decreto Legislativo n. 332 - 8 settembre 2000

"Attuazione della Direttiva 98/79/CE relativa ai Dispositivi Medico-Diagnostici in Vitro"

MEDICAL DEVICE LEGISLATION - D.L. n. 332 - 08 settembre 2000
Ministry of Health

Here you can find the link with the Italian Ministry of Health website.

Ministry of Health

Here you can find the Italian Medical Device Legislation link.

Medical Device Legislation - Italy