Such information may appear on the device itself, on packaging or as instructions for use. These documents should be developed and evaluated using risk management principles and usability engineering processes. Certain jurisdictions may require the inclusion of additional information. The following principles are recommended. Labeling The medium, format, content, legibility, and location of the labeling should be appropriate to the particular medical device or IVD medical device, its intended purpose, and intended to ensure safe and appropriate use, taking into consideration the following: user education; user training; any special needs of the persons for whom the device is intended; and the location and environment in which the device can be used. Country-specific requirements for the content of the labeling should be kept to the minimum and, where they currently exist, eliminated as the opportunity arises. Depending on the requirements of the RA having jurisdiction, labeling may be provided in one or more language(s). Languages may be identified using the plain text name of the language or a language code. The use of internationally recognised symbols in labeling should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the user. Where the meaning of the symbol is not obvious to the device user, e.g. for a newly introduced symbol, an explanation should be provided within the instructions for use. Residual risks that are to be communicated to the user and/or other persons should be included in the labeling. If required by the RA having jurisdiction, the labeling should include a summary of the performance studies and clinical investigations used to demonstrate conformance with regulatory review principles and that demonstrate the safety and clinical performance of the medical device or IVD medical device for its intended use. This summary should include but may not be limited to a summary of the investigation, clinical performance and outcome data, clinical safety information, and a summary of the clinical benefit. If not contained in the instructions for use, a reference should be included as to such information may be accessed.
Such information may appear on the device itself, on packaging or as instructions for use. These documents should be developed and evaluated using risk management principles and usability engineering processes. Certain jurisdictions may require the inclusion of additional information. The following principles are recommended. Labeling The medium, format, content, legibility, and location of the labeling should be appropriate to the particular medical device or IVD medical device, its intended purpose, and intended to ensure safe and appropriate use, taking into consideration the following: user education; user training; any special needs of the persons for whom the device is intended; and the location and environment in which the device can be used. Country-specific requirements for the content of the labeling should be kept to the minimum and, where they currently exist, eliminated as the opportunity arises. Depending on the requirements of the RA having jurisdiction, labeling may be provided in one or more language(s). Languages may be identified using the plain text name of the language or a language code. The use of internationally recognised symbols in labeling should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the user. Where the meaning of the symbol is not obvious to the device user, e.g. for a newly introduced symbol, an explanation should be provided within the instructions for use. Residual risks that are to be communicated to the user and/or other persons should be included in the labeling. If required by the RA having jurisdiction, the labeling should include a summary of the performance studies and clinical investigations used to demonstrate conformance with regulatory review principles and that demonstrate the safety and clinical performance of the medical device or IVD medical device for its intended use. This summary should include but may not be limited to a summary of the investigation, clinical performance and outcome data, clinical safety information, and a summary of the clinical benefit. If not contained in the instructions for use, a reference should be included as to such information may be accessed.
imdrf-cons-labeling-md-ivd-n52-180712.docx