Real Decreto por el que se regulan los Productos Sanitarios Implantables Activos (Real Decreto 1616/2009, de 26 de octubre)

Documentos citados

• Ley General de Publicidad (Ley 34/1988, de 11 de noviembre)
• Constitución Española de 1978 - Artículo 149
• Ley General de Sanidad (Ley 14/1986, de 25 de abril) - Artículos 27, 100, 102
• Ley Orgánica de Protección de Datos de Carácter Personal (Ley Orgánica 15/1999, de 13 de diciembre)
• Ley de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios (Ley 29/2006, de 26 de julio) - Artículos 3, 60



Ver todas las citas

• REAL DECRETO 634/1993, de 3 de Mayo, sobre Productos sanitarios implantables activos.
• ORDEN SCO/3603/2003, de 18 de diciembre, </strong>por la que<strong> se crean los Registros Nacionales de Implantes.
• Real Decreto por el que se regulan los Ensayos Clínicos con Medicamentos (Real Decreto 223/2004, de 6 de febrero)
• Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
• Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance
• Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)
• Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC Text with EEA relevance
• Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance)
• Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 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 concerning the placing of biocidal products on the market (Text with EEA relevance)
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives
• Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries
• Real Decreto 192/2023, de 21 de marzo, </strong>por el que<strong> se regulan los productos sanitarios.