D.P.R. of the 13th of March 1986 n. 128 “Regolamento di esecuzione delle norme di cui all’art. 189 del Testo Unico delle leggi sanitarie, approvato con Regio decreto 27 luglio 1934 n.1265, e successive modificazioni, in materia di produzione e commercio dei presidi medico-chirurgici” ("Regulation of the rules of Article. 189 Consolidation of sanitary laws, approved by Royal Decree n.1265 July 27, 1934, as amended, concerning the production and commercialisation of medical surgical devices”)

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  Decreto Ministeriale of the 3rd of March 1987 n. 133 “Assoggettamento alla disciplina dei presidi medico-chirurgici dei kit per la rivelazione di anticorpi anti HIV” ("Subjugation to the regulation of medical-surgical devices and kits for the detection of antibodies to HIV")
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  Decreto Ministeriale of the 12th of December 1991 “Assoggettamento dei reagenti per il rivelamento di HBsAg ed anti HCV alla disciplina dei presidi medico-chirurgici” ("Subjugation of reagents for detection of HBsAg and anti HCV in the regulation of medical devices")
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  Decreto Legislativo of the 24th of February 1997, n. 46 “Attuazione della direttiva 93/42/CEE, concernente i dispositivi medici” ("Implementation of Directive 93/42/EEC concerning medical devices")
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  D.P.R. of the 6th of October 1998 n. 392 “Regolamento recante norme per la semplificazione dei procedimenti di autorizzazione alla produzione ed all'immissione in commercio di presidi medicochirurgici, a norma dell'articolo 20, comma 8, della legge 15 marzo 1997, n. 59” ("Rules for the simplification of procedures for authorizing the production and marketing of medical-surgical devices, pursuant to Article 20, paragraph 8, of the Law of 15 March 1997, n° 59)
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  Decreto Legislativo n. 332 of the 8th of September 2000 “Attuazione della direttiva 98/79/CE relativa ai dispositivi medico-diagnostici in vitro” ("Implementation of Directive 98/79/EC on in vitro diagnostic medical devices")
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  Provvedimento of the 5th of February 1999 “Approvazione dei requisiti della domanda e relativa documentazione da presentare ai fini dell'autorizzazione all'immissione in commercio ed alla variazione di autorizzazioni già concesse per i presidi medico chirurgici” (“Approval of the requirements of the application and supporting documentation to be submitted for marketing authorization and the variation of existing authorisations for medical-surgical devices”)
• Directive 98/8/EC of the 16th of February 1998 “concerning the placing of biocidal products on the market”
• Decreto Legislativo n. 174 of the 25th of February 2000 “Attuazione della direttiva 98/8/EC in materia di immissione sul mercato di biocidi” ("Implementation of Directive 98/8/EC on the placing of biocidal products on the market")
• Regulation (EC) 1896/2000 of the 7th of September 2000 “on the first phase of the programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products”
• Regulation (EC) 2032/2003 of the 4th of November 2003 “on the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000”
• Regulation (EC) 1048/2005 of the13th of June 2005 “amending Regulation (EC) No 2032/2003 concerning the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market”
• Regulation (EC) 1849/2006 of the 14th of December 2006 “amending Regulation (EC) No 2032/2003 concerning the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market”
• Regulation (EC) 1451/2007 of the 4th of December 2007 “on the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market”
• Regulation (EC) 298/2010 of the 9th of April 2010 “amending Regulation (EC) No 1451/2007 as regards the extension of the duration of derogations allowing the placing of biocidal products on the market”
• Directive 2009/107/EC of the 16th of December 2009 “amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods”.
• COM (2009) 267 of the 12th of June 2009 “Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products”