Italy has adopted the 3 main European Directives on medical devices via the following laws:

• Decreto Legislativo n. 46 - 24 febbraio 1997
  Adoption of the EU Directive 93/42/CEE, regarding medical devices.

• Decreto Legislativo n. 507 - 14 dicembre 1992
  Adoption of the European Directive 90/385/CEE concerning the proximity of legislation of the Member States relative to active implantable medical devices.

• Decreto Legislativo n. 332 - 8 settembre 2000
  Adoption of the European Directive  98/79/CE relative to in vitro diagnostic medical devices (IVD).