National foreword

This British Standard is the UK implementation of EN ISO 14971:2019+A11:2021. It is derived from ISO 14971:2019. It supersedes BS EN ISO 14971:2019, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/210/4, Risk analysis for Medical Devices.

A list of organizations represented on this committee can be obtained on request to its committee manager.

This publication has been prepared under a mandate given to the European Standards Organizations by the European Commission and the European Free Trade Association. It is intended to support requirements of the EU legislation detailed in the European Foreword. A European Annex, usually Annex ZA or ZZ, describes how this publication relates to that EU legislation.

For the Great Britain market (England, Scotland and Wales), if UK Government has designated this publication for conformity with UKCA marking (or similar) legislation, it may contain an additional National Annex. Where such a National Annex exists, it shows the correlation between this publication and the relevant UK legislation. If there is no National Annex of this kind, the relevant Annex ZA or ZZ in the body of the European text will indicate the relationship to UK regulation applicable in Great Britain. References to EU legislation may need to be read in accordance with the UK designation and the applicable UK law. Further information on designated standards can be found at

www.bsigroup.com/standardsandregulation.

For the Northern Ireland market, UK law will continue to implement relevant EU law subject to periodic confirmation. Therefore Annex ZA/ZZ in the European text, and references to EU legislation, are still valid for this market.

UK Government is responsible for legislation. For information on legislation and policies relating to that legislation, consult the relevant pages of www.gov.uk.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2019.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice.

This third edition cancels and replaces the second edition (ISO 14971:2007), which has been technically revised. The main changes compared to the previous edition are as follows:

A clause on normative references has been included, in order to respect the requirements for fixed in Clause 15 of ISO/IEC Directives, Part 2:2018.
The defined terms are updated and many are derived from ISO/IEC Guide 63:2019. Defined terms are printed in italic to assist the reader in identifying them in the body of the document.
Definitions of benefit, reasonably foreseeable misuse and state of the art have been introduced.
More attention is given to the benefits that are expected from the use of the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations.
It is explained that the process described in ISO 14971 can be used for managing risks associated with medical devices, including those related to data and systems security.
The method for the evaluation of the overall residual risk and the criteria for its acceptability are required to be defined in the risk management plan. The method can include gathering and reviewing data and literature for the medical device and for similar medical devices and similar other products on the market. The criteria for the acceptability of the overall residual risk can be different from the criteria for acceptability of individual risks.
The requirements to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.
The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.
The requirements for production and post-production activities have been clarified and restructured. More detail is given on the information to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety.
Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised in parallel. More information and a rationale for the requirements in this third edition of ISO 14971 have been provided in Annex A. The correspondence between the clauses of the second edition and those of this third edition is given in Annex B.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

The requirements contained in this document provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.

This document was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years. This document could be used as guidance in developing and maintaining a risk managementprocess for other products that are not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the medical devicelife cycle.

This document deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment.

Risk management is a complex subject because each stakeholder can place a different value on the acceptability of risks in relation to the anticipated benefits. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.

It is generally accepted that the concept of risk has two key components:

the probability of occurrence of harm; and
the consequences of that harm, that is, how severe it might be.

All stakeholders need to understand that the use of a medical device involves an inherent degree of risk, even after the risks have been reduced to an acceptable level. It is well known that in the context of a clinical procedure some residual risks remain. The acceptability of a risk to a stakeholder is influenced by the key components listed above and by the stakeholder’s perception of the risk and the benefit. Each stakeholder’s perception can vary depending upon their cultural background, the socio-economic and educational background of the society concerned and the actual and perceived state of health of the patient. The way a risk is perceived also takes into account other factors, for example, whether exposure to the hazard or hazardous situation seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society.

As one of the stakeholders, the manufacturer reduces risks and makes judgments relating to the safety of a medical device, including the acceptability of residual risks. The manufacturer takes into account the generally acknowledged state of the art, in order to determine the suitability of a medical device to be placed on the market for its intended use. This document specifies a process through which the manufacturer of a medical device can identify hazards associated with the medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device.

The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure. Such decisions are beyond the scope of this document and take into account the intended use, the circumstances of use, the performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure. Some of these decisions can be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient or the patient’s own opinion.

For any particular medical device, other standards or regulations could require the application of specific methods for managing risk. In those cases, it is necessary to also follow the requirements outlined in those documents.

The verbal forms used in this document conform to the usage described in Clause 7 of the ISO/IEC Directives, Part 2:2018. For the purposes of this document, the auxiliary verb:

“shall” means that compliance with a requirement or a test is mandatory for compliance with this document;
“should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document;
“may” is used to describe permission (e.g. a permissible way to achieve compliance with a requirement or test);
“can” is used to express possibility and capability; and
“must” is used to express an external constraint that is not a requirement of the document.

This European Standard was approved by CEN on 5 August 2019.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

European foreword

This document (EN ISO 14971:2019) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2020, and conflicting national standards shall be withdrawn at the latest by June 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14971:2012.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 14971:2019 has been approved by CEN as EN ISO 14971:2019 without any modification.

European foreword to amendment A11

This document (EN ISO 14971:2019/A11:2021) has been prepared by Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN.

This Amendment to the European Standard EN ISO 14971:2019 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2022, and conflicting national standards shall be withdrawn at the latest by June 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This Amendment to the European Standard EN ISO 14971:2019 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports requirements of EU Regulation(s).

For relationship with EU Regulation(s), see informative Annex ZA, and ZB, which are an integral part of this document.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN websites.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

1 Scope

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnosticmedical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical devicelife cycle.

This document does not apply to:

decisions on the use of a medical device in the context of any particular clinical procedure; or
business risk management.

This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.

Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.

NOTE Guidance on the application of this document can be found in ISO/TR 24971^[⁹^].

2 Normative references

3 Terms and definitions

4 General requirements for risk management system

4.1 Risk managementprocess

4.2 Management responsibilities

4.3 Competence of personnel

4.4 Risk management plan

4.5 Risk management file

5 Risk analysis

5.1 Risk analysisprocess

5.2 Intended use and reasonably foreseeable misuse

5.3 Identification of characteristics related to safety

5.4 Identification of hazards and hazardous situations

5.5 Risk estimation

6 Risk evaluation

7 Risk control

7.1 Risk control option analysis

7.2 Implementation of risk control measures

7.3 Residual risk evaluation

7.4 Benefit-risk analysis

7.5 Risks arising from risk control measures

7.6 Completeness of risk control

8 Evaluation of overall residual risk

9 Risk management review

10 Production and post-production activities

10.1 General

10.2 Information collection

10.3 Information review

10.4 Actions

Bibliography

BS EN ISO 14971:2019+A11:2021

Medical devices. Application of risk management to medical devices

Current

Published:

31 Dec 2021