BS EN ISO 14971:2019+A11:2021

A11:2021: Annex ZA and Annex ZB added.

Annex ZA
(informative)

Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 a imed
to be covered.

For application of this European standard under Regulation (EU) 2017/745,

1. the scope is limited to medical devices and accessories for a medical device as defined in that Regulation and to products regulated as a
device under that Regulation;
2. in case of differences between terms defined in this European standard and terms defined in that Regulation, the terms defined in the
Regulation shall prevail;
3. the manufacturer’s policy for establishing criteria for risk acceptability (see 4.2 of this European standard) shall ensure that the criteria
comply with the General Safety and Performance Requirements of that Regulation.

So, explanation on the correspondence of the standard and the General Safety and Performance Requirements is included in Tabl e ZA.1.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to
be in compliance with Regulation (EU) 2017/745. This means that risks have to be ‘reduced as far as possible’, ‘reduced to th e lowest
possible level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possib le’, ‘eliminated or reduced as far as
possible’, ’removed or minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding General S afety and
Performance Requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety and Performance
Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.

NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.

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 Table ZA.1 – Correspondence between this European standard and Annex I of Regulation (EU) 2017/745 [OJ L 117]

General Safety andPerformance Requirements Clause(s) / subclause(s)of this EN Remarks / Notes

of Regulation (EU) 2017/745

4.1 to 4.5
4.1 Risk management process
The manufacturer shall establish, implement, document and
maintain an ongoing process for:
a) identifying hazards and hazardous situations associated
with a medical device;
b) estimating and evaluating the associated risks;
c) controlling these risks, and
d) monitoring the effectiveness of the risk control measures.
This process shall apply throughout the life cycle of the medical
device. This process shall include the following elements:
3, first paragraph — risk analysis;
‘Manufacturers shall establish, implement, document and — risk evaluation; Covered.
maintain a risk management system.’ — risk control; and
— production and post-production activities.
Where a documented product realization process exists, it shall
incorporate the appropriate parts of the risk management
process.

4.2 Management responsibilities

Top management shall provide evidence of its commitment to
the risk management process by ensuring:
— the provision of adequate resources; and
— the assignment of competent personnel (see 4.3) for risk
management.

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Top management shall define and document a policy for
establishing criteria for risk acceptability. The policy shall
provide a framework that ensures that criteria are based upon
applicable national or regional regulations and relevant
International Standards and take into account available
information such as the generally acknowledged state of the art
and known stakeholder concerns.

4.3 Competence of personnel

Persons performing risk management tasks shall be competent
on the basis of education, training, skills and experience
appropriate to the tasks assigned to them. Where appropriate,
these persons shall have knowledge of and experience with the
particular medical device (or similar medical devices) and its
use, the technologies involved or the risk management
techniques employed. Appropriate records shall be maintained.

4.4 Risk management plan

Risk management activities shall be planned. For the particular
medical device being considered, the manufacturer shall
establish and document a risk management plan in accordance
with the risk management process. The risk management plan
shall be part of the risk management file.
This plan shall include at least the following:
a) the scope of the planned risk management activities,
identifying and describing the medical device
and the life cycle phases for which each element of the plan is
applicable;
b) assignment of responsibilities and authorities;
c) requirements for review of risk management activities;
d) criteria for risk acceptability, based on the
manufacturer’s policy for determining acceptable risk, including

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 criteria for accepting risks when the probability of occurrence of
harm cannot be estimated;
e) a method to evaluate the overall residual risk, and criteria
for acceptability of the overall residual risk based on the
manufacturer’s policy for determining acceptable risk;
f) activities for verification of the implementation and
effectiveness of risk control measures; and
g) activities related to collection and review of relevant
production and post-production information.
If the plan changes during the life cycle of the medical device, a
record of the changes shall be maintained in the risk
management file.

4.5 Risk management file

For the particular medical device being considered, the
manufacturer shall establish and maintain a risk management
file. In addition to the requirements of other clauses of this
document, the risk management file shall provide traceability for
each identified hazard to:
— the risk analysis;
— the risk evaluation;
— the implementation and verification of the risk control
measures; and
— the results of the evaluation of the residual risks.
4.1, 4.2
4.1 Risk management process
3, second paragraph The manufacturer shall establish, implement, document and
‘Risk management shall be understood as a continuous maintain an ongoing process for:
iterative process throughout the entire lifecycle of a device, a) identifying hazards and hazardous situations associated Covered.
requiring regular systematic updating. In carrying out risk with a medical device;
management manufacturers shall:’ b) estimating and evaluating the associated risks;
c) controlling these risks, and
d) monitoring the effectiveness of the risk control measures.

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 This process shall apply throughout the life cycle of the medical
device. This process shall include the following elements:
— risk analysis;
— risk evaluation;
— risk control; and
— production and post-production activities.
Where a documented product realization process exists, it shall
incorporate the appropriate parts of the risk management
process.
4.2 Management responsibilities
Top management shall provide evidence of its commitment to
the risk management process by ensuring:
— the provision of adequate resources; and
— the assignment of competent personnel (see 4.3) for risk
management.
Top management shall define and document a policy for
establishing criteria for risk acceptability. The policy shall
provide a framework that ensures that criteria are based upon
applicable national or regional regulations and relevant
International Standards, and take into account available
information such as the generally acknowledged state of the art
and known stakeholder concerns.

4.4
4.4 Risk management plan
Risk management activities shall be planned. For the particular
medical device being considered, the manufacturer shall
3, item (a) establish and document a risk management plan in accordance Covered in respect of the
with the risk management process. The risk management plan process requirements.
(a) establish and document a risk management plan for each
shall be part of the risk management file.
device;
This plan shall include at least the following:
a) the scope of the planned risk management activities,
identifying and describing the medical device
and the life cycle phases for which each element of the plan is

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 applicable;
b) assignment of responsibilities and authorities;
c) requirements for review of risk management activities;
d) criteria for risk acceptability, based on the
manufacturer’s policy for determining acceptable risk, including
criteria for accepting risks when the probability of occurrence of
harm cannot be estimated;
e) a method to evaluate the overall residual risk, and criteria
for acceptability of the overall residual risk based on the
manufacturer’s policy for determining acceptable risk;
f) activities for verification of the implementation and
effectiveness of risk control measures; and
g) activities related to collection and review of relevant
production and post-production information.
If the plan changes during the life cycle of the medical device, a
record of the changes shall be maintained in the risk
management file.
5
5 Risk analysis
5.1 Risk analysis process
The manufacturer shall perform risk analysis for the particular
medical device as described in 5.2 to 5.5. The implementation of
the planned risk analysis activities and the results of the risk
analysis shall be recorded in the risk management file.
In addition to the records required in 5.2 to 5.5, the
3, item (b) documentation of the conduct and results of the risk analysis Covered in respect of the
process requirements.
(b) identify and analyse the known and foreseeable hazards shall include at least the following: Device- specific execution of
associated with each device; a) identification and description of the medical device that
was analysed; the process is not covered.
b) identification of the person(s) and organization who
carried out the risk analysis; and
c) scope and date of the risk analysis.

5.2 Intended use and reasonably foreseeable misuse

The manufacturer shall document the intended use of the

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particular medical device being considered.
The intended use should take into account information such as
the intended medical indication, patient population, part of the
body or type of tissue interacted with, user profile, use
environment, and operating principle.
The manufacturer shall also document reasonably foreseeable
misuse.
This documentation shall be maintained in the risk management
file.

5.3 Identification of characteristics related to safety

For the particular medical device being considered, the
manufacturer shall identify and document those qualitative and
quantitative characteristics that could affect the safety of the
medical device. Where appropriate, the manufacturer shall
define limits of those characteristics. This documentation shall
be maintained in the risk management file.

5.4 Identification of hazards and hazardous situations

The manufacturer shall identify and document known and
foreseeable hazards associated with the medical device based on
the intended use, reasonably foreseeable misuse and the
characteristics related to safety in both normal and fault
conditions.
For each identified hazard, the manufacturer shall consider the
reasonably foreseeable sequences or combinations of events
that can result in a hazardous situation, and shall identify and
document the resulting hazardous situation(s).

5.5 Risk estimation

For each identified hazardous situation, the manufacturer shall
estimate the associated risk(s) using available information or
data. For hazardous situations for which the probability of the

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 occurrence of harm cannot be estimated, the possible
consequences shall be listed for use in risk evaluation and risk
control. The results of these activities shall be recorded in the
risk management file.
The system used for qualitative or quantitative categorization of
probability of occurrence of harm and severity of harm shall be
recorded in the risk management file.

5.5, 6
5.5 Risk estimation
For each identified hazardous situation, the manufacturer shall
estimate the associated risk(s) using available information or
data. For hazardous situations for which the probability of the
occurrence of harm cannot be estimated, the possible
consequences shall be listed for use in risk evaluation and risk
control. The results of these activities shall be recorded in the
risk management file.
The system used for qualitative or quantitative categorization of
probability of occurrence of harm and severity of harm shall be
recorded in the risk management file.
3, item (c) Covered in respect of the
(c) estimate and evaluate the risks associated with, and process requirements.
occurring during, the intended use and during reasonably 6 Risk evaluation Device- specific execution of
foreseeable misuse; For each identified hazardous situation, the manufacturer shall the process is not covered.
evaluate the estimated risks and determine if the risk is
acceptable or not, using the criteria for risk acceptability defined
in the risk management plan.
If the risk is acceptable, it is not required to apply the
requirements given in 7.1 to 7.5 to this hazardous situation (i.e.,
proceed to 7.6) and the estimated risk shall be treated as
residual risk.
If the risk is not acceptable, then the manufacturer shall perform
risk control activities as described in 7.1 to 7.6.
The results of this risk evaluation shall be recorded in the risk
management file.

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 7
7 Risk control
7.1 Risk control option analysis
The manufacturer shall determine risk control measures that are
appropriate for reducing the risks to an acceptable level.
The manufacturer shall use one or more of the following risk
control options in the priority order listed:
a) inherently safe design and manufacture;
b) protective measures in the medical device itself or in the
manufacturing process;
c) information for safety and, where appropriate, training to
users.
The risk control measures selected shall be recorded in the risk
management file.
If, during risk control option analysis, the manufacturer
determines that risk reduction is not practicable, the
manufacturer shall conduct a benefit-risk analysis of the residual Covered in respect of the
3, item (d)
risk (proceed to 7.4). process requirements.
(d) eliminate or control the risks referred to in point (c) in Device- specific execution of
accordance with the requirements of Section 4; 7.2 Implementation of risk control measures the process is not covered.
The manufacturer shall implement the risk control measures
selected in 7.1.
Implementation of each risk control measure shall be verified.
This verification shall be recorded in the risk management file.

7.3 Residual risk evaluation

After the risk control measures are implemented, the
manufacturer shall evaluate the residual risk using the criteria
for risk acceptability defined in the risk management plan. The
results of this evaluation shall be recorded in the risk
management file.
If a residual risk is not judged acceptable using these criteria,
further risk control measures shall be considered (go back to
7.1).

7.4 Benefit-risk analysis

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If a residual risk is not judged acceptable using the criteria
established in the risk management plan and further risk control
is not practicable, the manufacturer may gather and review data
and literature to determine if the benefits of the intended use
outweigh this residual risk.
If this evidence does not support the conclusion that the benefits
outweigh this residual risk, then the manufacturer may consider
modifying the medical device or its intended use (go back to 5.2).
Otherwise, this risk remains unacceptable.
If the benefits outweigh the residual risk, then proceed to 7.5.
The results of the benefit-risk analysis shall be recorded in the
risk management file.

7.5 Risks arising from risk control measures

The manufacturer shall review the effects of the risk control
measures with regard to whether:
— new hazards or hazardous situations are introduced; or
— the estimated risks for previously identified hazardous
situations are affected by the introduction of the risk control
measures.
Any new or increased risks shall be managed in accordance with
5.5 to 7.4.
The results of this review shall be recorded in the risk
management file.

7.6 Completeness of risk control

The manufacturer shall review the risk control activities to
ensure that the risks from all identified hazardous situations
have been considered and all risk control activities are
completed. The results of this review shall be recorded in the
risk management file.

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 10
10 Production and post-production activities
10.1 General
The manufacturer shall establish, document and maintain a
system to actively collect and review information relevant to the
medical device in the production and post-production phases.
When establishing this system, the manufacturer shall consider
appropriate methods for the collection and processing of
information.

10.2 Information collection

The manufacturer shall collect, where applicable:
a) information generated during production and monitoring
of the production process;
b) information generated by the user;
c) information generated by those accountable for the
3, item (e) installation, use and maintenance of the
(e) evaluate the impact of information from the production medical device; Covered in respect of the
phase and, in particular, from the post-market surveillance d) information generated by the supply chain; process requirements.
system, on hazards and the frequency of occurrence thereof, e) publicly available information; and Device- specific execution of
on estimates of their associated risks, as well as on the f) information related to the generally acknowledged state the process is not covered.
overall risk, benefit-risk ratio and risk acceptability; and of the art.

The manufacturer shall also consider the need to actively collect

and review publicly available information about similar medical
devices and similar other products on the market.

10.3 Information review

The manufacturer shall review the information collected for
possible relevance to safety, especially
whether:
— previously unrecognised hazards or hazardous situations
are present;
— an estimated risk arising from a hazardous situation is no
longer acceptable;
— the overall residual risk is no longer acceptable in
relation to the benefits of the intended use; or
— the generally acknowledged state of the art has changed.

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 The results of the review shall be recorded in the risk
management file.

10.4 Actions
If the collected information is determined to be relevant to
safety, the following actions apply.
1) Concerning the particular medical device,
— the manufacturer shall review the risk management file
and determine if reassessment of risks and/or assessment of
new risks is necessary;
— if a residual risk is no longer acceptable, the impact on
previously implemented risk control measures shall be
evaluated and should be considered as an input for modification
of the medical device;
— the manufacturer should consider the need for actions
regarding medical devices on the market; and
— any decisions and actions shall be recorded in the risk
management file.
2) Concerning the risk management process,
— the manufacturer shall evaluate the impact on previously
implemented risk management activities; and
— the results of this evaluation shall be considered as an
input for the review of the suitability of the risk management
process by top management (see 4.2).
10.4
10.4 Actions
If the collected information is determined to be relevant to
safety, the following actions apply.
1) Concerning the particular medical device,
3, item (f) — the manufacturer shall review the risk management file Covered in respect of the
(f) based on the evaluation of the impact of the information and determine if reassessment of risks and/or assessment of process requirements.
referred to in point (e), if necessary, amend control measures new risks is necessary; Device- specific execution of
in line with the requirements of Section 4. — if a residual risk is no longer acceptable, the impact on the process is not covered.
previously implemented risk control measures shall be
evaluated and should be considered as an input for modification
of the medical device;
— the manufacturer should consider the need for actions
regarding medical devices on the market; and

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 — any decisions and actions shall be recorded in the risk
management file.
2) Concerning the risk management process,
— the manufacturer shall evaluate the impact on previously
implemented risk management activities; and
— the results of this evaluation shall be considered as an
input for the review of the suitability of the risk management
process by top management (see 4.2).
4.2, 4.4, 6, 7, 8
8 Evaluation of overall residual risk
After all risk control measures have been implemented and
verified, the manufacturer shall evaluate the overall residual risk
posed by the medical device, taking into account the
contributions of all residual risks, in relation to the benefits of
4, first paragraph the intended use, using the method and the criteria for
Risk control measures adopted by manufacturers for the acceptability of the overall residual risk defined in the risk
design and manufacture of the devices shall conform to safety management plan [see 4.4 e)].
principles, taking account of the generally acknowledged Covered in respect of the
If the overall residual risk is judged acceptable, the manufacturer
state of the art. To reduce risks, Manufacturers shall manage shall inform users of significant residual risks and shall include process requirements.
risks so that the residual risk associated with each hazard as the necessary information in the accompanying documentation Device- specific execution of
well as the overall residual risk is judged acceptable. In the process is not covered.
in order to disclose those residual risks.
selecting the most appropriate solutions, manufacturers If the overall residual risk is not judged acceptable in relation to
shall, in the following order of priority: the benefits of the intended use, the manufacturer may consider
implementing additional risk control measures (go back to 7.1)
or modifying the medical device or its intended use (go back to
5.2). Otherwise, the overall residual risk remains unacceptable.
The results of the evaluation of the overall residual risk shall be
recorded in the risk management file.
4.2, 4.4, 6, 7 are mentioned above.
7.1 a) Covered in respect of the
4, item (a)
The manufacturer shall use one or more of the following risk process requirements.
eliminate or reduce risks as far as possible through safe
control options in the priority order listed: Device- specific execution of
design and manufacture;
a) inherently safe design and manufacture; the process is not covered.

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 4, item (b) 7.1 b)
(b) where appropriate, take adequate protection measures, The manufacturer shall use one or more of the following risk Covered in respect of the
including alarms if necessary, in relation to risks that cannot control options in the priority order listed: process requirements.
be eliminated; and b) protective measures in the medical device itself or in the Device- specific execution of
manufacturing process; the process is not covered.

4, item (c) 7.1 c) Covered in respect of the

(c) provide information for safety c) information for safety and, where appropriate, training to process requirements.
(warnings/precautions/contra-indications) and, where users. Device- specific execution of
appropriate, training to users. the process is not covered.
8 (second paragraph)
If the overall residual risk is judged acceptable, the manufacturer
4, last paragraph
shall inform users of significant residual risks and shall include Covered.
Manufacturers shall inform users of any residual risks.
the necessary information in the accompanying documentation
in order to disclose those residual risks.
5, item (a)
Covered in respect of the
In eliminating or reducing risks related to use error, the
process requirements.
manufacturer shall: 5.2, 5.3, 5.4, 7 Device- specific and
(a) reduce as far as possible the risks related to the These items are mentioned above. usability-specific execution
ergonomic features of the device and the environment in of the process is not
which the device is intended to be used (design for patient covered.
safety), and
5, item (b) Covered in respect of the
(b) give consideration to the technical knowledge, process requirements.
experience, education, training and use environment, where 5.2, 5.3, 5.4 Device- specific and
applicable, and the medical and physical conditions of These items are mentioned above. usability-specific execution
intended users (design for lay, professional, disabled or other of the process is not
users). covered.
8
8. All known and foreseeable risks, and any undesirable Covered in respect of the
side-effects, shall be minimised and be acceptable when 6, 7, 8 process requirements.
weighed against the evaluated benefits to the patient and/or These items are mentioned above. Device- specific execution of
user arising from the achieved performance of the device the process is not covered.
during normal conditions of use.

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9
9. For the devices referred to in Annex XVI, the general
safety requirements set out in Sections 1 and 8 shall be
understood to mean that the device, when used under the Covered, provided that the
1 to 10 criteria for risk acceptability
conditions and for the purposes intended, does not present a
All of the items are mentioned above. are established in
risk at all or presents a risk that is no more than the
maximum acceptable risk related to the product's use which accordance with GSPR 9.
is consistent with a high level of protection for the safety and
health of persons.

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