This 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 Referenced Document
CEN/TR 15133 Nomenclature - Collective terms and codes for groups of medical devices*, 2022-12-02 Update
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 3166-1 Codes for the representation of names of countries and their subdivisions - Part 1: Country code (ISO 3166-1:2020)*, 2020-09-16 Update
ISO 1000 SI units and recommendations for the use of their multiples and of certain other units; Amendment 1
ISO 639-1 Codes for the representation of names of languages - Part 1: Alpha-2 code
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
EN 1041:2008 history
2013EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
2008EN 1041:2008 Information supplied by the manufacturer of medical devices
1998EN 1041:1998 Information Supplied by the Manufacturer with Medical Devices