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The Official Journal of the European Union of 18 February 2004 publishes the reference to the standard EN ISO 14971:2000/AC:2002 Medical devices - Application of risk management to medical devices in the framework of the Directive 90/385/EEC on active implantable medical devices. That standard is since then considered as "harmonised" and therefore confers a presumption of conformity to the directive when used for the design and production of such devices.
The reference of that standard was previously published on 31 July 2002 in the framework of directives 93/42/EEC concerning medical devices and 98/79/EC on in vitro diagnostic medical devices.
Read the corresponding communication in: English, français, nederlands.
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