Directiva 2007/47/CE del Parlamento Europeo y del Consejo, de 5 de septiembre de 2007, por la que se modifica la Directiva 90/385/CEE del Consejo relativa a la aproximación de las legislaciones de los Estados miembros sobre los productos sanitarios implantables activos, la Directiva 93/42/CEE del Consejo relativa a los productos sanitarios y la...

Afectaciones

MODIFICA

•   Directiva 90/385/CEE del Consejo, de 20 de junio de 1990, relativa a la aproximación de las legislaciones de los Estados Miembros sobre los productos sanitarios implantables activos          

IMPLEMENTADA por

• Real Decreto por el que se regula el Proceso de Evaluación para el Registro, Autorización y Comercialización de Biocidas (Real Decreto 1054/2002, de 11 de octubre)
• Real Decreto por el que se regulan los Productos Sanitarios (Real Decreto 1591/2009, de 16 de octubre)

INCORPORADA por

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

CORREGIDA por

• Correccción de errores de la Directiva 2007/47/CE del Parlamento Europeo y del Consejo, de 5 de septiembre de 2007, por la que se modifica la Directiva 90/385/CEE del Consejo relativa a la aproximación de las legislaciones de los Estados miembros sobre los productos sanitarios implantables activos, la Directiva 93/42/CEE del Consejo relativa a los productos sanitarios y la Directiva 98/8/CE relativa a la comercialización de biocidas ( DO L 247 de 21.9.2007 )
• Corrección de errores de la Directiva 2007/47/CE del Parlamento Europeo y del Consejo, de 5 de septiembre de 2007, por la que se modifica la Directiva 90/385/CEE del Consejo relativa a la aproximación de las legislaciones de los Estados miembros sobre los productos sanitarios implantables activos, la Directiva 93/42/CEE del Consejo relativa a los productos sanitarios y la Directiva 98/8/CE relativa a la comercialización de biocidas ( DO L 247 de 21.9.2007 )

Documentos citados

• Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma
• Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
• Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission Three statements in the Council minutes relating to this Decision are set out in OJ C 203 of 17 June, page 1. (1999/468/EC)
• Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances



Ver todas las citas

• Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
• 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 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
• Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)Text with EEA relevance
• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (Text with EEA relevance)Text with EEA relevance
• Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations
• Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty
• 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
• Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC)
• Commission Directive 2007/20/EC of 3 April 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include dichlofluanid as an active substance in Annex I thereto (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)
• 2006/512/EC: Council Decision of 17 July 2006 amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency
• 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
• Treaty establishing the European Community