PD CEN ISO/TR 24971:2020

PD CEN ISO/TR 24971:2020

Medical devices. Guidance on the application of ISO 14971

Status : Current   Published : June 2020



PD CEN ISO/TR 24971:2020 is available with tracked changes. To learn more and buy, click HERE. 

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
TitleMedical devices. Guidance on the application of ISO 14971
Publication Date19 June 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2019
Informative References(Provided for Information)ISO 16142-1, IEC 60601-1, IEC 62502, ISO 22367, IEC Guide 120:2018, ISO 23640, IEC 60812, AAMI TIR 57:2016, IEC 61326-2-6, ISO 15197, ISO 14155, ISO 17511, ISO/TS 17822-1, ISO/IEC Guide 63:2019, IEC TR 62366-2, ISO 15189, IEC 61882, ISO 22442 (series), ISO 20776 (series), IEC TR 60601-4-1, IEC 61025, ISO 20916, IEC 80001-1:2010, IEC 62304:2006, ISO 10993-1:2018, IEC 62366-1:2015/COR1:2016, ISO 13485:2016, IEC 61010-2-101:2015, ISO 17593, IEC 60601-2-16, IEC 60601-1-2, ISO/TR 20416, IEC 60601-1-8, ISO/DIS 10017, ISO Handbook: ISO 13485:2016, ISO 11608-1, ISO 16142-2, ISO 18113 (all parts)
ReplacesPD ISO/TR 24971:2013
International RelationshipsCEN ISO/TR 24971:2020,ISO/TR 24971:2020
Amended ByCorrigendum, July 2020
DescriptorsElectrical medical equipment, Terminology, Medical equipment, Sets of data, Databases, Data representation, Data processing, Medical instruments, Information exchange, Thesauri, Data structures, Data handling, Data organization, Classification systems
Title in FrenchDispositifs médicaux. Directives relatives à l'ISO 14971
Title in GermanMedizinprodukte. Leitfaden zur Anwendung von ISO 14971
ISBN978 0 580 52399 1
File Size3.464 MB

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