EN 1041:2008+A1:2013 PDF

Scope: 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. 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. 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. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE 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.

EN 1041:2008+A1:2013 Referenced Document

EN ISO 3166-1:2006 Codes for the Representation of Names of Countries and Their Subdivisions - Part 1: Country Codes*， 2024-04-20 Update
ISO 1000:1992 SI units and recommendations for the use of their multiples and of certain other units
ISO 639-1:2002 Codes for the representation of names of languages - Part 1: Alpha-2 code
ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times

2013 EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
2008 EN 1041:2008 Information supplied by the manufacturer of medical devices
1998 EN 1041:1998 Information Supplied by the Manufacturer with Medical Devices