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About This Item

 

Full Description

BS EN 1041:2008 specifies the 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. 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.

BS EN 1041:2008 is intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on the way that the requirements can be met. If a manufacturer follows BS EN 1041, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.

BS EN 1041:2008 does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards.

When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
 

Document History

  1. BS EN 1041:2008+A1:2013


    Information supplied by the manufacturer of medical devices

    • Most Recent
  2. BS EN 1041:2008

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    Information supplied by the manufacturer of medical devices

    • Historical Version
  3. BS 06/30123163 DC


    BS EN 1041. Information supplied by the manufacturer with medical devices

    • Historical Version
  4. BS EN 1041:1998


    Information supplied by the manufacturer with medical devices

    • Historical Version