EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices EN 1041:2008+A1:2013

Publication date:   Jan 21, 2014

General information

99.60 Withdrawal effective   May 5, 2021

CEN/CENELEC

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

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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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

90/385/EEC

Active implantable medical devices

Life cycle

NOW

WITHDRAWN
EN 1041:2008+A1:2013
99.60 Withdrawal effective
May 5, 2021

REVISED BY

PUBLISHED
EN ISO 20417:2021