It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. ![]() Historical BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices (British Standard)
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