User guide

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MAN 01/EN/03 CRONO PAR 50 06/13
REFERENCE DIRECTIVES
• Council Directive 93/42/EEC: Medical devices.
• Legislative Decree no. 46, 24th February 1997. Implementation of Council
Directive 93/42/EEC concerning medical devices.
• Directive 2007/47/EC of the European Parliament and of the Council:
Amending Council Directive 90/385/EEC on the approximation of the laws of
the Member States relating to active implantable medical devices, Council
Directive 93/42/EEC concerning medical devices and Directive 98/8/EC con-
cerning the placing of biocidal products on the market.
• Legislative Decree No. 37, 25 January 2010. Implementation of Directive
2007/47/EC.
APPENDIX 8