Regulation
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).
The three decrees have been amended with the Law Decree 25 gennaio 2010, n.37 that is the national implementation of the new EU directive 2007/47/CE, amending directives 90/385/CE, 93/42/CEE, and 98/8/CE. Dir. 2007/47/EC came into force on March, 21st 2010.
The full texts of the amended decrees are available at the following links:
- Law Decree 24 febbraio 1997, n. 46, as ameded by Law Decree 25 gennaio 2010, n. 37
- Law Decree 14 dicembre 1992, n. 507, as amended by Law Decree 25 gennaio 2010, n. 37
- Law Decree 8 settembre 2000, n. 332, as amended by Law Decree 25 gennaio 2010, n. 37