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English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
The Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993. [8] The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990. [9] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10]
Directive 98/27/EC on injunctions for the protection of consumers' interests, repealed by Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests. [6] Directive on alternative consumer dispute resolution, Directive 2013/11/ΕU, issued on 21 May 2013. [7]
This directive is the codified version of Directive 89/392/EEC as amended by the directives listed above. Machine Directive 1998/37/EC This was amended by the following directive: Directive 98/79/EC has been a minor amendment relating to the exclusion of medical devices. Machinery Directive 98/37/EC remained in force until 29 December 2009.
The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. [citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), [2] effective on 26 May 2021. [3]
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)
Directive 2002-87-EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73-239-EEC, 79-267-EEC, 92-49-EEC, 92-96-EEC, 93-6-EEC and 93-22-EEC, and Directives 98-78-EC and 2000-12-EC of the European Parliament and of the ...