Directiva 98/79/CE del Parlamento Europeo y del Consejo, de 27 de octubre de 1998, sobre productos sanitarios para diagnóstico in vitro

Afectaciones

APLICADA por

• Decisión de la Comisión, de 2 de diciembre de 2008, relativa a la aplicación del artículo 8 de la Directiva 98/79/CE del Parlamento Europeo y del Consejo [notificada con el número C(2008) 7378]

IMPLEMENTADA por

• Real Decreto sobre Productos Sanitarios para Diagnóstico 'In Vitro' (Real Decreto 1662/2000, de 29 de septiembre)
• Corrección de errores del Real Decreto 1662/2000, de 29 de septiembre, sobre productos sanitarios para diagnóstico 'in vitro'.

MODIFICADA por

• Directiva 2011/100/UE de la Comisión, de 20 de diciembre de 2011, por la que se modifica la Directiva 98/79/CE del Parlamento Europeo y del Consejo sobre productos sanitarios para diagnóstico in vitro - Artículos : anexo

DEROGADA PARCIALMENTE por

• Reglamento (UE) 2017/746 del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios para diagnóstico in vitro y por el que se derogan la Directiva 98/79/CE y la Decisión 2010/227/UE de la Comisión

Documentos citados

• Commission Directive 97/69/EC of 5 December 1997 adapting to technical progress for the 23rd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance)
• 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
• 87/373/EEC: Council Decision of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission
• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• 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



Ver todas las citas

• Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations
• Council Directive of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (89/336/EEC)
• Commission Directive 96/65/EC of 11 October 1996 adapting to technical progress for the fourth time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and modifying Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings (Text with EEA relevance)
• Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits)
• Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
• Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery
• 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
• Council Directive 89/617/EEC of 27 November 1989 amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement
• 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 Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
• Treaty establishing the European Community