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EN 1041:1998

Information supplied by the manufacturer with medical devices EN 1041:1998

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Aug 6, 2008

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 standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN 1041:1998
99.60 Withdrawal effective
Aug 6, 2008

REVISED BY

WITHDRAWN
EN 1041:2008