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

Afectaciones

DEROGA PARCIALMENTE

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

DEROGA

• Decisión de la Comisión, de 19 de abril de 2010, relativa a la Base de Datos Europea sobre Productos Sanitarios (Eudamed) [notificada con el número C(2010) 2363]

CORREGIDA por

• Corrección de errores del 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 (DO L 117 de 5.5.2017)
• Corrección de errores del 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 ( DO L 117 de 5 de mayo de 2017 )

Documentos citados

• Orifarm A/S and Others (C-400/09) and Paranova Danmark A/S and Paranova Pack A/S (C-207/10) v Merck Sharp & Dohme Corp. and Merck Sharp & Dohme BV and Merck Sharp & Dohme.
• Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
• Council Directive 71/354/EEC of 18 October 1971 on the approximation of the laws of the Member States relating to units of measurement
• 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
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )



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• Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (Text with EEA relevance)
• 87/95/EEC: Council Decision of 22 December 1986 on standardization in the field of information technology and telecommunications
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• 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
• Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data
• Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)Text with EEA relevance
• Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft
• Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)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 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare
• 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
• Charter of fundamental rights of the European Union
• Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance
• Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Text with EEA relevance
• Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses
• 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 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels (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)
• Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC)
• Consolidated version of the Treaty on the Functioning of the European Union 2016/C 202/01
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• Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres
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• Tratado de la Unión Europea