Hazard identification is the foundation of the entire risk management process. An unidentified hazard is an unmanaged risk — it will not appear in the analysis, will not be subject to any control measure, and will not be covered by the benefit/risk assessment. If such a hazard materialises after the device is placed on the market, the manufacturer cannot demonstrate that it had anticipated and managed the situation.
Section 5.4 of ISO 14971:2019 requires the manufacturer to identify the qualitative and quantitative characteristics of the device that may affect safety, as well as the foreseeable hazards, hazardous situations and harms.
The sources of hazard identification
A comprehensive list of hazards cannot be obtained by filling in a generic template. It is built by cross-referencing several sources.
The intended use and normal conditions of use. The first source, but insufficient on its own. It covers the risks in the ideal use scenario — which is never the only real-world scenario.
Reasonably foreseeable misuse. This is the most frequently underexploited source. ISO 14971 requires identifying not only the risks associated with correct use, but also those associated with reasonably foreseeable misuse: use by an untrained professional, use in an unintended indication, configuration error, or omission of a preparation step. The usability standard IEC 62366 provides a structured method for analysing these scenarios.
The physical, chemical and biological characteristics of the device. Material properties (potential toxicity, biocompatibility), mechanical properties (strength, wear, fatigue), electrical properties (for active devices), and thermal properties.
Historical data on similar devices. Clinical publications on known failure modes, vigilance data from other manufacturers (available in the public databases of competent authorities and in EUDAMED), and incident reports from authorities (FDA MAUDE, ANSM database).
Post-market feedback on previous versions of the device. If the manufacturer has been marketing this device for several years, past complaints and incidents are a valuable source of hazards that were not initially anticipated.
How to document completeness
Notified bodies cannot verify that every possible hazard has been identified — there is no universal list of hazards. What they verify is that the identification process was systematic and documented.
The documentation must show which sources were consulted, according to which method, and with what scope. A list of hazards without documentation of the identification process leaves the auditor unable to assess its completeness.