ISO TR 24971-2020 PDF

Full title and description

ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971. This technical report provides non‑mandatory, practical guidance to support the implementation, maintenance and use of a risk management process for medical devices in accordance with ISO 14971:2019.

Abstract

This technical report explains and illustrates key concepts from ISO 14971:2019, offering examples, clarifications and recommended approaches for hazard identification, risk analysis, risk evaluation (including benefit‑risk considerations), risk control and post‑production information. It identifies how the risk management process can interact with a quality management system (for example ISO 13485:2016) and includes informative annexes addressing specific topics such as in vitro diagnostic devices.

General information

• Status: Published
• Publication date: 16 June 2020 (June 2020)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.01 (Medical equipment and supplies)
• Edition / version: Edition 2 (2020)
• Number of pages: 87

(Publication and bibliographic details per the ISO record and IEC webstore.)

Scope

Provides guidance on the development, implementation and maintenance of a risk management system for medical devices that applies ISO 14971:2019. The report addresses how to identify hazards and hazardous situations, perform risk analysis and evaluation, establish risk acceptability criteria and perform benefit‑risk analysis, define and implement risk controls, and collect and use production and post‑production information. It is informative only and does not add new normative requirements beyond ISO 14971.

Key topics and requirements

• Guidance on establishing and documenting a risk management process aligned with ISO 14971:2019.
• Hazard identification techniques and examples of hazard‑related considerations.
• Risk analysis and estimation methods (qualitative and quantitative approaches).
• Risk evaluation, risk acceptability criteria and benefit‑risk analysis guidance.
• Design and implementation of risk controls and verification of their effectiveness.
• Integration of production and post‑production information into ongoing risk management.
• Informative annexes including examples and specific guidance for in vitro diagnostic devices.

These topics are explanatory and intended to help manufacturers apply the normative requirements of ISO 14971 in practice.

Typical use and users

Primary users are medical device manufacturers, design and development teams, risk managers, regulatory and quality professionals, conformity assessment bodies, and consultants who implement or assess risk management systems for medical devices. The report is used as a practical companion to ISO 14971 when drafting procedures, performing risk assessments, and preparing technical documentation.

Related standards

Directly related to ISO 14971:2019 (Application of risk management to medical devices) and commonly used alongside ISO 13485:2016 (quality management for medical devices). ISO/TR 24971:2013 is the previous technical report that was withdrawn and replaced by the 2020 edition. The report is produced under the activities of ISO/TC 210.

Keywords

risk management, medical devices, ISO 14971, guidance, hazard identification, risk analysis, risk evaluation, risk control, post‑production information, IVD guidance, ISO/TC 210.

FAQ

Q: What is this standard?

A: ISO/TR 24971:2020 is a technical report offering guidance — not new normative requirements — on how to apply ISO 14971:2019 risk management principles to medical devices.

Q: What does it cover?

A: It covers practical explanations and examples for establishing a risk management process, hazard identification, risk analysis and evaluation, benefit‑risk considerations, risk control measures, and integration of post‑production information. It also includes informative annexes with device‑type specific guidance (for example IVDs).

Q: Who typically uses it?

A: Medical device manufacturers, quality and regulatory personnel, risk managers, conformity assessment bodies and consultants use this report as a companion to ISO 14971 when implementing and assessing risk management systems.

Q: Is it current or superseded?

A: The 2020 edition (Edition 2) is the current published technical report, published in June 2020; it replaced the 2013 edition which was withdrawn. Stability information listed by publishers indicates the document is current as of its stated stability date.

Q: Is it part of a series?

A: It is a technical report produced under ISO/TC 210 and serves as an informative companion to the normative ISO 14971 standard; it sits alongside other ISO documents relevant to medical device quality and safety (for example ISO 13485).

Q: What are the key keywords?

A: Risk management, medical devices, ISO 14971, guidance, hazard identification, risk analysis, risk evaluation, risk control, post‑market surveillance, IVD (in vitro diagnostics).