EN 1041:2008/FprA1

Information supplied by the manufacturer of medical devices EN 1041:2008/FprA1

General information

50.60 Close of voting. Proof returned by secretariat   Jun 10, 2013


CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

01.110   Technical product documentation | 11.040.01   Medical equipment in general | 11.120.01   Pharmaceutics in general


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).

Related legislation

Legislation related to this standard


Medical devices


Active implantable medical devices

Life cycle


EN 1041:2008


EN 1041:2008/FprA1
50.60 Close of voting. Proof returned by secretariat
Jun 10, 2013