Registration number (WIID)Project No.TitleStatus
64861CEN/TR 17223:2018Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices RegulationAtcelts
24145CEN/TR 15133:2005Nomenclature - Collective terms and codes for groups of medical devicesAtcelts
18858LVS CR 14060:2003Medical device traceabilityAtcelts
64029EN ISO 13485:2016/AC:2016Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)Atcelts
24416CEN ISO/TR 14969:2005Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)Atcelts
38595EN ISO 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)Atcelts
12987LVS CR 13217:2001Nomenclature system for medical devices for the purpose of regulatory data exchange - RationaleAtcelts
22133LVS EN ISO 13485:2003Medical devices - Quality management systems - System requirements for regulatory purposesAtcelts
18856EN ISO 14971:2000Medical devices - Application of risk management to medical devices (ISO 14971:2000)Atcelts
24766EN 980:2008Symbols for use in the labelling of medical devicesAtcelts
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