Understanding Technical Reports in International Standards

The Framework of International Standards: “What” vs. “How”

International standards issued by organizations such as ISO and IEC contain only the “What”—that is, what must be accomplished—rather than the “How,” or the specific methods for accomplishing those objectives. This limitation exists because if standards were to prescribe specific implementation methods in detail, non-compliance with those exact procedures could result in findings or observations from regulatory authorities or certification bodies, even if the underlying requirements were met through alternative approaches.

However, the absence of “How” guidance creates a practical challenge: organizations are left uncertain about the specific means of implementing and demonstrating compliance with stated requirements. To resolve this dilemma, ISO and IEC address this gap by publishing documents known as Technical Reports (TRs). These documents serve a distinct and important function in the regulatory and standards landscape.

The Regulatory Status of Technical Reports

A Technical Report is not itself a requirement but rather illustrative guidance or reference material. Consequently, Technical Reports serve as informational resources to support organizations in implementing standards, but compliance with a Technical Report is not mandatory. Organizations are not required to follow the approaches outlined in Technical Reports; rather, any approach that satisfies the underlying standard requirements is acceptable. In essence, Technical Reports provide one possible path to compliance, but alternative, equally valid methods exist. This distinction is critical: while Technical Reports represent expert consensus on implementation methodologies, they are not normative requirements.

Key Technical Reports in Medical Device Regulation

The medical device industry relies on several important Technical Reports that clarify how standards should be practically implemented.

IEC/TR 80002-1, “Medical Device Software—Part 1: Guidance on the Application of ISO 14971 to Medical Device Software,” provides detailed guidance on how to apply risk management principles (ISO 14971) within the context of the software development lifecycle requirements specified in IEC 62304. This Technical Report translates abstract risk management concepts into concrete, actionable steps for medical device software developers.

ISO/TR 80002-2, “Medical Device Software—Part 2: Validation of Software Used in the Context of the Medical Device Quality System,” elaborates on the software validation requirements found in ISO 13485:2016—specifically in sections 4.1.6, 7.5.6, and 7.6—offering practical methodologies and examples for demonstrating software validation in quality management systems.

Evolution of Risk Management Standards and the Role of Technical Reports

Risk management has undergone significant developments in the medical device industry. ISO 14971:2007, “Medical Devices—Application of Risk Management to Medical Devices,” was revised and superseded by ISO 14971:2019. To support this transition, ISO/TR 24971, “Medical Devices—Guidance on the Application of ISO 14971,” was issued as the corresponding Technical Report.

A noteworthy aspect of this revision is the treatment of annexes (Annex C, F, and J) that were present in ISO 14971:2007. In ISO 14971:2019, these annexes were removed and transferred to ISO/TR 24971, thereby shifting their status from normative requirements to informative reference material. This structural change has important implications: it grants organizations greater flexibility in designing and implementing risk management processes, allowing them to select risk management methodologies that align with their specific business contexts and risk profiles, rather than being constrained to a single prescribed approach.

Practical Considerations When Using Technical Reports

When leveraging Technical Reports in regulatory and compliance strategies, several important considerations apply. While Technical Reports represent the collective expertise of international specialists and provide reliable, authoritative guidance, regulatory authorities’ and notified bodies’ interpretations may occasionally differ from or evolve beyond the content of a given Technical Report. Consequently, it is essential to recognize that the approaches outlined in a Technical Report, while valuable, do not represent the sole pathway to compliance. Organizations should understand that alternative approaches meeting the underlying requirements may be equally acceptable.

This flexibility is particularly important in rapidly evolving regulatory environments and emerging technology domains. In such areas, regulatory authorities may issue new guidance after a Technical Report has been published, or they may interpret requirements in ways that differ from or expand upon Technical Report content. Therefore, while Technical Reports are valuable tools for understanding standards and implementing them effectively, they should be considered as guidance rather than absolute prescriptions, and organizations should remain attentive to evolving regulatory expectations and authority interpretations.