Over the last several years, there have been numerous changes to regulations and standards that have increased emphasis on the industry’s need to understand the relationship between risk management and labeling. Updates to Risk Management (per ISO 14971:2019), the release of the ISO standard on Information to be Supplied by the Manufacturer (ISO 20417:2020) and, more specifically, changes to the EU regulations on medical devices (EU MDR 2017/745) and in vitro diagnostics (IVDs) (EU IVDR 2017/746) have all reinforced the important role of risk management in driving communication to end users and patients.
However, one main issue with communicating risks to users/patients is that there are no clear instructions on how to determine what category of communication should be applied for each risk. Furthermore, the standards and regulations do not clearly define these key terms.
Access NAMSA’s latest White Paper, “The Relationship Between Risk Management and Labeling,” as we discuss potential definitions that can be used by manufacturers for quality systems to help categorize information regarding safety and residual risks. We also highlight, through the use of these definitions, how risks may translate into precautions, warnings, contraindications and limitations per ISO 20417, 21 CFR Part 801, the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR).
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