NLMedicalDevices object

Applicable national regulations

Transposition of EU Directives on MD
Other

Transposition of Directive 90/385/EEC

Legislative Decree n. 507/92 (Decreto lgs. n. 507/92) on Non active implantable medical devices, as amended by Legislative Decree n. 37/2010 (Decreto lgs. N.37/2010) implementing Directive 2007/47/EC.

Transposition of Directive 93/42/EEC

Legislative Decree n. 46/97 (Decreto lgs. n. 46/97) on medical devices, as amended by Legislative Decree n. 37/2010 (Decreto lgs. N.37/2010) implementing Directive 2007/47/EC.

Transposition of Directive 98/79/EC

Legislative Decree n. 332/2000 (Decreto lgs. n. 332/2000) on in vitro diagnostic medical devices (implementing Directive 98/79/EC), as amended by Legislative Decree n. 37/2010 (Decreto lgs. N.37/2010) implementing Directive 2007/47/EC.

Other applicable regulations / implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

Ministerial Decree, 2 Aug 2005. Official Journal n. 210 September 9, 2005 (Decreto del Ministero della Salute, 2 agosto 2005: Modalita' di presentazione della documentazione per notifica di indagine clinica con dispositivi medici)

Additional Information

In addition, internationally accepted documents such as the Declaration of Helsinki and ISO 14155:2011 apply to all categories of clinical investigations of MD.
European regulatory requirements European Directive (2001/20/EC) additionally apply to combination studies.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395