PD CEN ISO/TR 24971:2020 - TC

PD CEN ISO/TR 24971:2020 - TC

Tracked Changes. Medical devices. Guidance on the application of ISO 14971

Status : Current   Published : August 2020


What is a tracked changes standard?

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

PD CEN ISO/TR 24971:2020 Medical devices — Application of risk management to medical devices is a key horizontal standard for the medical device market, guiding manufacturers in the development, implementation and maintenance of a risk management process for medical devices.

This document – PD CEN ISO/TR 24971:2020 – is a Published Document and the UK implementation of an international Technical Report that gives guidance on conforming to BS EN ISO 14971:2019.

Who is PD CEN ISO/TR 24971:2020 for?

  •   Medical device manufacturers
  •   Regulators
  •   Other users of BS EN ISO 14971


Why should you use PD CEN ISO/TR 24971:2020?

It gives guidance to help manufacturers develop, implement and maintain a risk management process for all medical devices that aim to meet the requirements of BS EN ISO 14971. It covers a wide variety of medical devices including active, non-active, implantable and non-implantable medical devices, software as medical devices and in vitro diagnostic medical devices.

The clauses and sub-clauses in PD CEN ISO/TR 24971:2020 have the same structure and numbering as the clauses and sub-clauses of BS EN ISO 14971:2019. Further division into sub-clauses is applied where considered useful. The informative annexes contain additional guidance on specific aspects of risk management.

NOTE 1: Alternative approaches to those supplied in PD CEN ISO/TR 24971:2020 may be used if these satisfy the requirements of BS EN ISO 14971:2019.

NOTE 2: When judging the applicability of the guidance in this document, users should consider the nature of the medical device(s) to which it will apply, how these medical devices are used, and the applicable regulatory requirements.


PD CEN ISO/TR 24971:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages because it supports risk management of medical devices.



How has PD CEN ISO/TR 24971:2020 changed since the last update?

This is a complete technical revision.

-     Clauses in ISO/TR 24971:2013 and some informative annexes from BS EN ISO 14971:2007 have been merged, restructured, technically revised and supplemented with additional guidance

-     To make the document easier to use, it has the same structure and numbering of clauses and sub-clauses as BS EN ISO 14971:2019 

-     The informative annexes contain additional guidance on specific aspects of risk management

Standard NumberPD CEN ISO/TR 24971:2020 - TC
TitleTracked Changes. Medical devices. Guidance on the application of ISO 14971
Publication Date14 August 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2019
Informative References(Provided for Information)ISO 22367, ISO 15189, IEC 60601-1, ISO 11608-1, AAMI TIR 57:2016, IEC Guide 120:2018, IEC 60601-1-8, IEC TR 60601-4-1, IEC 60601-2-16, ISO 17511, IEC 61326-2-6, ISO 16142-2, IEC 61882, IEC TR 62366-2, ISO Handbook: ISO 13485:2016, ISO 18113 (all parts), ISO 17593, IEC 62502, IEC 61025, IEC 60601-1-2, DIS 10017, IEC 60812, IEC 80001-1:2010, ISO 13485:2016, IEC 61010-2-101:2015, ISO 10993-1:2018, IEC 62304:2006, IEC 62366-1:2015/COR1:2016, ISO 22442 (series), ISO 23640, TR 20416, IEC Guide 63:2019, ISO 15197, ISO 20776 (series), ISO 20916, ISO 14155, TS 17822-1, ISO 16142-1
DescriptorsData structures, Sets of data, Databases, Data representation, Data organization, Information exchange, Medical instruments, Thesauri, Terminology, Data processing, Electrical medical equipment, Classification systems, Data handling, Medical equipment
Title in FrenchDispositifs médicaux. Directives relatives à l'ISO 14971
Title in GermanMedizinprodukte. Leitfaden zur Anwendung von ISO 14971
ISBN978 0 539 14677 6
File Size4.548 MB

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