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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.
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 ...
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Directive 98/27/EC on injunctions for the protection of consumers' interests, repealed by Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests.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 [citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), [2] effective on 26 May 2021.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 98/79/EC regarding in vitro diagnostic medical devices (Until 2022, the In Vitro Diagnosis Regulation (IVDR) will replace the EU's current Directive on In-Vitro Diagnostic (98/79/EC)). They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market.
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC. [6] ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF). [7]