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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.
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.
Directive 98/27/EC on injunctions for the protection of consumers' interests, repealed by Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests.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]
The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10] The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB).
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 [citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), [2] effective on 26 May 2021.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]
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