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SRPS EN 1041:2014

Information supplied by the manufacturer of medical devices

Jul 31, 2014

General information

90.92     Jun 30, 2020

ISS

Z076

European Norm

01.110     11.120.01     11.040.01  

English  

za komisiju Medicinska sredstva

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 1041:2010

NOW

PUBLISHED
SRPS EN 1041:2014
90.92 Standard to be revised
Jun 30, 2020

Related project

Adopted from EN 1041:2008+A1:2013