DS/EN 1041 + A1:2013

Information supplied by the manufacturer of medical devices


Status:
Current
Type:
Standard
Language:
DA;EN
Subject:
Price from:
€ 96.59
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Links

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.


Number of pages: 56

Published: 2013-10-25

Date of approval: 2013-11-27

International relationships : EN 1041:2008+A1:2013 IDT

ICS: 01.110 - Technical product documentation 11.040.01 - Medical equipment in general 11.120.01 - Pharmaceutics in general

Item number: M284376


Committees

Committee

  • CENCLC/JTC 3
  • CENCLC/JTC 3/WG 1

Danish committee

DS/S-257