M/433 - Graphical symbols
Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC, amending Directive 93/42/EEC relating to Medical Devices, concerning graphical symbols for use in the labelling of medical devices containing phthalates
Mandate M/433 directs CEN and CENELEC to develop standardized graphical symbols for labeling medical devices containing phthalates, in line with Directive 2007/47/EC amending Directive 93/42/EEC on medical devices. The mandate aims to ensure clear and consistent communication about the presence of phthalates in medical device labeling, enhancing user safety and regulatory compliance. The decision on the approval of this mandate is referenced under CEN/BT C3/2009.
Purpose
This mandate is aimed at the development of harmonised graphical symbols to be used on the labelling of medical devices that contain phthalates. It supports Directive 2007/47/EC, which amends Directive 93/42/EEC concerning medical devices, by providing clear visual information to users about the presence of phthalates in these devices.
Standardisation request
The mandate requests the European Standardisation Organisations CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) to develop and establish a set of standardised graphical symbols. These symbols should be suitable for labelling medical devices containing phthalates in order to ensure harmonised communication across the EU market.
Expected deliverables
The expected deliverable from this mandate is a set of standard graphical symbols designed specifically for labelling medical devices containing phthalates. These symbols should comply with the requirements of the amended medical devices Directive and facilitate clear identification, thereby enhancing safety and informed use of such medical devices.
Context
The mandate is situated within the regulatory framework of Directive 2007/47/EC, which amends Directive 93/42/EEC on medical devices. The inclusion of graphical symbols is part of efforts to improve transparency and user awareness regarding chemical substances in medical devices, particularly concerning phthalates, which may have health implications. The mandate's resolution reference is CEN/BT C3/2009, indicating its adoption by the CEN Technical Board.
This mandate covers the standardisation of graphical symbols used in the labelling of medical devices that contain phthalates. It relates specifically to medical devices within the scope of Directive 2007/47/EC amending Directive 93/42/EEC.
General Information
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
- Standard12 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/433 is a European Standardization Mandate titled "Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC, amending Directive 93/42/EEC relating to Medical Devices, concerning graphical symbols for use in the labelling of medical devices containing phthalates". Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC, amending Directive 93/42/EEC relating to Medical Devices, concerning graphical symbols for use in the labelling of medical devices containing phthalates There are 2 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.