oSIST prEN ISO 18969:2026

SLOVENSKI STANDARD
01-februar-2026
Klinično ovrednotenje medicinskih pripomočkov (ISO/DIS 18969:2025)
Clinical evaluation of medical devices (ISO/DIS 18969:2025)
Klinische Bewertung von Medizinprodukten (ISO/DIS 18969:2025)
Evaluation clinique des dispositifs médicaux (ISO/DIS 18969:2025)
Ta slovenski standard je istoveten z: prEN ISO 18969
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 18969
ISO/TC 194
Clinical evaluation of medical
Secretariat: DIN
devices
Voting begins on:
Evaluation clinique des dispositifs médicaux
2025-12-15
Voting terminates on:
ICS: 11.040.01
2026-03-09
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 18969:2025(en)
DRAFT
ISO/DIS 18969:2025(en)
International
Standard
ISO/DIS 18969
ISO/TC 194
Clinical evaluation of medical devices
Secretariat: DIN
Evaluation clinique des dispositifs médicaux
Voting begins on:
ICS: 11.040.01
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 18969:2025(en)
ii
ISO/DIS 18969:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and Abbreviations. 5
5 General requirements . 6
5.1 Purpose of the clinical evaluation .6
5.2 Management Responsibilities .7
5.3 Clinical evaluation process .7
5.4 Clinical evaluation quality management .8
5.5 Competencies relevant for the clinical evaluation.9
5.6 Documentation of the clinical evaluation .9
6 Clinical evaluation considerations throughout the life cycle . 9
6.1 Overall considerations .9
6.2 Planning considerations during design and development .10
7 Clinical evaluation planning .11
7.1 General .11
7.2 Identifying medical and non-medical alternatives . 12
7.3 Identification of data sources for available knowledge . 13
7.4 Identification of data sources for the device under evaluation.14
7.4.1 Non-clinical data relevant to the device under evaluation .14
7.4.2 Clinical data relevant to the device under evaluation .14
7.5 Special considerations . 15
7.5.1 Transferability of clinical data . 15
7.5.2 Medical devices with special clinical evaluation considerations . 15
7.5.3 Considerations for the level of clinical evidence . 15
8 Clinical evaluation conduct and documenting .16
8.1 Available knowledge .16
8.2 Device under evaluation .16
8.2.1 Data collection .16
8.2.2 Data appraisal .17
8.2.3 Data analysis and conclusions .17
9 Overall assessment .18
9.1 General considerations.18
9.2 Safety.18
9.3 Clinical performance or effectiveness, including clinical benefit(s) .18
9.4 Benefit-risk profile .19
9.5 Limitations .19
10 Final conclusions .20
11 Additional activities .20
12 Update of the clinical evaluation .21
Annex A (informative) Clinical evaluation documentation: suggested outline .22
Annex B (informative) Methodology for data search - literature search .27
Annex C (informative) Appraisal of data.30
Annex D (informative) Analysis of data .32
Annex E (informative) Clinical evaluation activities during medical device life cycle stages .33

iii
ISO/DIS 18969:2025(en)
Annex ZA (informative) Relationship between this European standard and the requirements
of Regulation (EU) 2017/745 aimed to be covered .35
Bibliography .42

iv
ISO/DIS 18969:2025(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 194, Biological and clinical evaluation of medical
devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
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.

v
ISO/DIS 18969:2025(en)
Introduction
This document specifies a clinical evaluation process by which clinical evidence is obtained from the pre-
clinical and clinical use of medical devices to verify their safety and clinical performance or effectiveness,
including clinical benefit(s).
The readers of this document are encouraged take into account the importance of linking the clinical
evaluation process into other processes, especially to design and development, risk management and
regulatory strategy.
The flowcharts embedded in this document are intended to assist the readers in obtaining a better
understanding of the activities associated with the clinical evaluation process during the medical device life
cycle and especially supporting design and development.
The clinical evaluation process is an iterative and modular process. Not all requirements of this document
apply to each device type or medical device life cycle phase.
For the purpose of this document, the use of the term compliance is applied when compliance to this
document's requirements is required. In case of requirements outlined in regulatory documents or other
standards, the term 'conformance with' is applied.

vi
DRAFT International Standard ISO/DIS 18969:2025(en)
Clinical evaluation of medical devices
1 Scope
This document specifies, principles and a process for the clinical evaluation of medical devices. This
document specifies how to plan and perform clinical evaluation, including the collection, appraisal and
analysis of data to assess the safety and, clinical performance or effectiveness, including clinical benefit(s) of
medical devices, and to evaluate the acceptability of clinical risks when weighed against the clinical benefits
achieved when the device under evaluation (DUE) is used as intended by the manufacturer. This includes the
determination whether there is evidence for the assessment.
This document also:
— defines the responsibilities of the manufacturer and those conducting or contributing to a clinical
evaluation on behalf of the manufacturer,
— assists manufacturers, regulatory authorities and other stakeholders involved in the process or
assessment of the clinical evaluation of medical devices and,
— provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of
conclusions.
This document does not apply to in vitro diagnostic medical devices.
NOTE 1 National regulations can have additional or different requirements.
NOTE 2 Some of the principles of this document can apply to actors other than manufacturers involved in clinical
evidence generation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2019, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp

ISO/DIS 18969:2025(en)
3.1
adverse event
untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including
abnormal laboratory findings) in patients, users or other persons, related to the DUE, independent of risk
level and whether anticipated or unanticipated
Note 1 to entry: Regional definition may apply and override the meaning of this term.
[SOURCE: ISO 14155:2020, 3.2 - modified by replacing the 'investigational device' by 'DUE' and added
'independent of risk level'; Original notes have not been included]
3.2
available knowledge
known and accessible clinical and non-clinical information
Note 1 to entry: State of the art (3.28) is a subset of available knowledge (3.2).
3.3
clinical benefit
positive impact of a device on the health of an individual expressed in terms of a meaningful measurable
patient-relevant clinical outcome (3.10)(s), including outcome(s) related to treatment, diagnosis, or a positive
impact on patient management or public health
3.4
clinical condition
clinical, medical, physiological, or pathological condition the device is intended to treat, diagnose or manage
3.5
clinical data
information generated from the clinical use (3.14) of a medical device
3.6
clinical development
process to generate clinical evidence (3.8)
3.7
clinical evaluation
set of continuous activities that use scientifically sound methods for the assessment and analysis of clinical
data (3.5) and relevant non-clinical data (3.5) to verify the safety (3.24) and clinical performance (3.12)
or effectiveness (3.17), including clinical benefit (3.3) of the medical device when used as intended by the
manufacturer
[1]
[SOURCE: IMDRF MDCE WG/N56final:2019; clinical evaluation ]
3.8
clinical evidence
results of the evaluation of clinical data (3.5) and relevant non-clinical data (3.5) pertaining to a medical device
[1]
[SOURCE: IMDRF MDCE WG/N56final:2019; clinical evaluation ]
3.9
clinical investigation
clinical trial
clinical study
systematic investigation in one or more human subjects, undertaken to assess the safety (3.24) and clinical
performance (3.12) or effectiveness (3.17), including clinical benefit(s) (3.3) of a medical device
[SOURCE: ISO 14155:2020, 3.8 - modified by adding 'including clinical benefit(s)']

ISO/DIS 18969:2025(en)
3.10
clinical outcome
measurable change in symptoms, overall health, ability to function, quality of life, or survival outcomes that
result from giving care to patients or outcome in patient management
Note 1 to entry: For diagnostic devices, the clinical outcome (3.10) relates to the capability of providing accurate
medical information on individuals, where appropriate, assessed with other available medical information, and where
health management may be dependent on further diagnostic or therapeutic options which could be available for the
healthcare professional.
Note 2 to entry: For devices intended for patient management, the clinical outcomes can relate to reliability of the
displayed information or improved workflow management.
Note 3 to entry: For devices intended to deliver a drug, the clinical outcome (3.10) relates to the precision and accuracy
of drug delivery, enhance patient adherence and compliance, and improve disease management and control.
3.11
clinical outcome parameter
specified, measurable indicator used to assess the clinical outcome (3.10)
Note 1 to entry: The purpose of the clinical outcome parameter (3.11) is to objectively measure the intended clinical
benefit (3.3)(s) to the patients, and where relevant, to users and public health. The evaluation criteria (3.18) for the
clinical outcome parameter (3.11) can be derived from the relevant standards and medical consensus guidelines in
patient care or other sources of available knowledge (3.2).
3.12
clinical performance
ability of a device, resulting from any direct or indirect medical effects which stem from its technical or
functional characteristics, including diagnostic characteristics, to achieve its intended purpose (3.22) as
claimed by the manufacturer, thereby leading to a clinical benefit (3.3) for patients, when used as intended
by the manufacturer
3.13
clinical risk
combination of the probability of occurrence of harm and the severity of that harm to health of people
resulting from the medical device, when the device is used as intended for its medical purpose
Note 1 to entry: Harm to the health of people in the context of the clinical evaluation (3.7) is only relevant, if the harm
is directly associated with the clinical use (3.14) of the device.
3.14
clinical use
use of a medical device on humans for treatment, diagnosis or patient management purposes
3.15
clinically relevant claim
direct or indirect assertion made by the manufacturer pertaining to the safety (3.24), clinical performance
(3.12) or effectiveness (3.17) including clinical benefit (3.3)(s) of a medical device when used as intended
Note 1 to entry: Claims are commonly made in the instructions for use, promotional material(s), websites or other
media controlled by the manufacturer.
3.16
digital evidence
results of computational modelling and simulation or artificial intelligence (AI)-based analysis, used as part
of an evaluation provided in a prescribed format that encompass in silico trials in silico tests and synthetic
clinical data (3.5)
Note 1 to entry: Digital evidence (3.16) is also known as in silico evidence and can be derived from clinical and non-
clinical data.
[SOURCE: Modified from Avicenna Alliance (2023), Avicenna Alliance Glossary Terms for Computer
[2]
Modelling and simulation (3rd ed.) ]

ISO/DIS 18969:2025(en)
3.17
effectiveness
ability of a medical device to achieve clinically meaningful outcome(s) in its Intended use (3.22) as claimed
by the manufacturer
[1]
[SOURCE: IMDRF MDCE WG/N56final:2019; clinical evaluation ]
3.18
evaluation criteria
set of predetermined reference conditions that serve as a basis for evaluation or comparison to demonstrate
that the expected clinical outcome parameters (3.11) are met
Note 1 to entry: Determined based on outcomes achievable with other state of the art (3.28) and standard of care
(3.27), therapeutic or non-therapeutic alternatives(including diagnostic options), with the same intended use (3.22)
or patient population. evaluation criteria (3.18) can be derived from product specific standards or medical consensus
guidelines.
Note 2 to entry: Evaluation criteria (3.18) for specific clinical outcomes are measurable and preferably quantitative,
but may be expressed as a range with confidence intervals, where applicable.
3.19
expected lifetime
time period specified by the manufacturer during which the medical device or accessory is expected to
remain safe and effective for use
Note 1 to entry: The expected lifetime (3.19) can be affected by the stability.
Note 2 to entry: Maintenance, repairs or upgrades (e.g. safety (3.24) or cybersecurity modifications) can be necessary
during the expected lifetime (3.19).
Note 3 to entry: Some medical devices have an absolute lifetime (e.g. 5 y), whereas other medical devices (e.g. software)
have a relative lifetime (e.g. the time between two major releases).
[SOURCE: ISO 20417:2021, 3.7 – modified by deleting Note 4 to entry]
3.20
life cycle
series of all phases in the life of a medical device (3.10), from the initial conception to final decommissioning
and disposal
[4]
[SOURCE: ISO/IEC Guide 63:2019, 3.5]
3.21
information provided to the user
information provided by the manufacturer on the label, in the instructions for use or in promotional, training
or sales materials or statements accessible (oral or written) to the user
3.22
intended use
intended purpose
use for which a medical device is intended according to the specifications, instructions and information
provided by the manufacturer
Note 1 to entry: Intended use (3.22) can include indications for use.
3.23
performance
ability of a medical device to achieve its intended purpose (3.22) as stated by the manufacturer
Note 1 to entry: Performance (3.23) may include both clinical and technical aspects.
[5]
[SOURCE: IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) ]

ISO/DIS 18969:2025(en)
3.24
safety
freedom from unacceptable risk
[4]
[SOURCE: ISO/IEC Guide 63:2019, 3.10]
3.25
similar device
medical devices that share the same or similar intended use (3.22), technology or principle of operation but
can differ in specific design or materials
Note 1 to entry: The word 'similar' in this document does not have any regulatory connotation, but refers to devices
that can provide relevant clinical or technical data to support clinical evaluation (3.7), with adequate justification.
3.26
simulated use
non-clinical evaluation of a medical device’s performance (3.23), usability, and safety (3.24) by replicating
intended clinical scenarios using artificial models, virtual environments, or simulated physiological
conditions, without involving actual patients or human subject
3.27
standard of care
treatment or diagnosis that experts agree is appropriate, accepted, and widely used for a given disease or
clinical condition (3.4)
Note 1 to entry: Standard of care (3.27) can vary from one geographic region to another.
3.28
state of the art
developed stage of technical capability at a given time as regards products, processes and services, based on
the relevant consolidated findings of science, technology and experience
Note 1 to entry: The state of the art (3.28) embodies what is currently and generally accepted as good practice in
technology and medicine. The state of the art (3.28) does not necessarily imply the most technologically advanced
solution. The state of the art (3.28) described here is sometimes referred to as the “generally acknowledged state of the
art (3.28).
Note 2 to entry: State of the art (3.28) is a subset of available knowledge (3.2).
[5]
[SOURCE: IMDRF GRRP WG/N47 FINAL:2024 modified by adding Note to Entry 2]
4 Symbols and Abbreviations
AI Artificial Intelligence
DUE Device Under Evaluation
IFU Instructions for Use
QMS Quality Management System
RWD Real World Data
SOTA State of the Art
WET Well Established Technologies

ISO/DIS 18969:2025(en)
5 General requirements
5.1 Purpose of the clinical evaluation
The purpose of clinical evaluation is to assess safety and clinical performance or effectiveness including
clinical benefit(s), and acceptability of the benefit-risk profile of the DUE. This ensures that patients,
healthcare providers and other users have access to effective medical devices and are safeguarded from
potential unacceptable risks associated with their use.
The objective of clinical evaluation is to determine whether the DUE meets specified requirements for safety,
clinical performance or effectiveness including clinical benefit(s) and the benefit-risk profile within its life
cycle. These requirements shall be specified in relation to medical or non-medical alternatives for the same
patient population and indications or intended use, as applicable.
The clinical evaluation process is an iterative assessment, and its objectives are dependent on the stage of
the medical device life cycle. For example, in early development, when clinical data are not yet available, the
clinical evaluation will focus on the evaluation of other available medical and non-medical alternatives with
the aim of determining safety and performance requirements, including, where applicable, relevant clinical
outcome parameters and associated evaluation criteria.
In mid-development, the objective may shift to defining clinical evidence requirements. In late development
of the medical device life cycle, clinical evaluation may be performed with the objective of determining if
adequate clinical evidence exists to demonstrate that the identified evaluation criteria have been met.
In the post-market phase, the objectives shift to evaluation of real-world data and any impacts of the
evolution of the available knowledge. Further information can be found in Table E.1.
NOTE 1 It is the manufacturer's responsibility to identify medical or non-medical alternatives and, if applicable, the
appropriate target patient population.
The clinical evaluation shall address, where applicable:
a) all medical device models, variants and combinations;
NOTE 2 Clinical evidence from one model or combination can be used, if needed, provided adequate rationale
and justification for transferability of data is documented.
b) intended use, including all indications for use and specifics of intended patient populations, as applicable;
c) intended user(s);
d) conditions of use;
e) risks identified through risk management and review of the available knowledge;
f) risks and benefits identified from clinical and relevant non-clinical data;
g) potential risks from misuse or off-label use;
h) duration of use, including potential long-term impacts of medical devices intended to be used for a
limited period of time;
i) expected medical device lifetime
j) use of the DUE in combination with other devices and products.
The clinical evaluation shall provide a basis to determine the need for additional clinical or other relevant
data, including pre-or post-market data, as necessary.
NOTE 3 The clinical evaluation can serve as evidence of conformance with the relevant essential principles.

ISO/DIS 18969:2025(en)
5.2 Management Responsibilities
The manufacturer is responsible for the clinical evaluation within the medical device life cycle. Top
management shall demonstrate its commitment to the clinical evaluation by implementing and maintaining
a clinical evaluation process, ensuring the provision of adequate resources and assigning competent
personnel to conduct the clinical evaluation and related tasks.
The manufacturer shall ensure a clear and strong interaction between the processes of clinical evaluation,
design and development, risk management, clinical development, regulatory strategy and post-market
surveillance.
5.3 Clinical evaluation process
Clinical evaluation is an essential part of medical device design and development and is closely linked to the
risk management process through the identification, analysis and assessment of clinical risks and benefits
(see Figure 1). The manufacturer shall make a reasoned decision on the type and scope of the clinical
evaluation. This decision depends on the type of medical device and the clinical risk potential.
Figure 1 — Clinical evaluation process interfaces
The clinical evaluation process includes planning, collection, appraisal and analysis of clinical and non-
clinical data relevant to a DUE using a methodologically sound procedure and coming to a conclusion and
recommendation for further generation of pertinent data (see Figure 2).

ISO/DIS 18969:2025(en)
Figure 2 — Overall clinical evaluation process
5.4 Clinical evaluation quality management
[6]
The clinical evaluation process shall be formalized within the QMS procedures (e.g. ISO 13485:2016 ).
Quality management principles shall apply to the clinical evaluation process to ensure the documentation is
version-controlled and appropriate documentation links are identified.
QMS processes shall ensure a clear and strong interaction between the processes of clinical evaluation,
design and development, risk management, clinical development, regulatory strategy and post market
surveillance (see Figure 1 ).
ISO/DIS 18969:2025(en)
5.5 Competencies relevant for the clinical evaluation
Teams performing or reviewing the clinical evaluation shall include individuals who are competent based on
education, training, skills or experience appropriate to the tasks assigned to them. Relevant competencies
and knowledge which shall be considered during planning include:
a) research methodology (including clinical investigation design and biostatistics);
b) information management (e.g. experience with relevant databases and search strategies);
c) relevant regulatory requirements;
d) medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and
experience in medical writing, systematic review and clinical data appraisal);
e) relevant medical device technology and its application;
f) relevant clinical expertise such as diagnosis or management of the condition(s) or use(s) for which the
DUE is intended, including medical alternatives and standard of care.
NOTE Clinical evaluation tasks can be performed by different individuals, each contributing their specialist
knowledge. The individual competencies can change between early during device development compared with later in
the medical device life cycle.
5.6 Documentation of the clinical evaluation
The clinical evaluation of the DUE shall be appropriately documented. A suggested outline for the clinical
evaluation documentation can be found in Annex A. The clinical evaluation documentation can consist of a
single document or multiple documents. The format of the documentation can vary based on the device type
or the stage of the clinical evaluation or regulatory requirements.
NOTE The extent and contents of the documentation and document controls can differ based on the objective
of the clinical evaluation. For example, a clinical evaluation conducted early during device development can differ
from a clinical evaluation conducted later in the medical device life cycle. The manufacturer can define adequate
documentation and control procedures within the QMS.
Considering that clinical evaluation is a continuous process, the clinical evaluation documentation can
be prepared as a single document that is periodically updated. Alternatively, new documentation can be
generated with each update. Additionally, the documentation should reflect when certain information is
either unavailable at the time of preparation or when certain information does not apply to the current
clinical evaluation.
6 Clinical evaluation considerations throughout the life cycle
6.1 Overall considerations
Clinical evaluation activities shall start early during design and development of the medical device. During
this phase, the clinical evaluation activities shall contribute to the identification of evaluation criteria for
safety and clinical performance or effectiveness, including clinical benefit(s) derived from medical or non-
medical alternatives, if available. The results can also impact the medical device design specifications or
methods for generating clinical and other relevant data (see Figure 1).
Later in the process, clinical evaluation shall be used to support the planning of clinical development,
including clinical investigations in accordance with ISO 14155, 6.3, if needed, and to demonstrate the safety
and clinical performance or effectiveness, including clinical benefit(s) of the DUE.
The clinical evaluation is a continuous process with periodic updates of its documentation within the
medical device life cycle (see Clause 12).
An overview of clinical evaluation activities during medical device life cycles stage can be found in Annex E.

ISO/DIS 18969:2025(en)
6.2 Planning considerations during design and development
During design and development of the DUE, clinically relevant user requirements are defined and then
further translated into a target intended use with related safety and clinical performance or effectiveness,
including clinical benefit(s) through searches and analyses of available knowledge. Such searches and
analyses provide relevant input for the design of any clinical investigation(s), when required in accordance
with ISO 14155:2020, 6.3.
Furthermore, to enable access to safe and effective medical devices, it is important to consider local
requirements. Tailoring medical devices to the need of healthcare system of each jurisdiction requires a
holistic evaluation of complex clinical factors, including but not limited to patient demographics, user skill
sets, and use environment(s). For instance, patient demographics can differ. Also, a modified device may
be necessary for use for example in remote, low-resource, or rural areas, which could expand access to
healthcare by enabling new care pathways that accommodate other target users with different skill sets and
capabilities.
The risk and clinical benefit outputs from the searches and analyses of available knowledge, starting at
early stage of product development and within the life cycle of the DUE, shall be used as input to the risk
management activities in accordance with ISO 14971:2019.
The clinical evaluation planning for determining the scope shall start alongside the medical device design
and development planning phase following the specification of user requirements.
A strong cross-functional team collaboration, linking the processes of clinical evaluation, design and
development, clinical development, risk management, regulatory strategy and post-market surveillance
is required (see 5.2). Such collaboration shall lead to the development of several elements of the clinical
evaluation scope including when applicable:
a) intended use;
b) intended target patient population;
c) preliminary product description;
d) indication(s) for use;
e) contraindications;
f) limitations (e.g. maximum number of allowed reuses);
g) warnings;
h) precautions;
i) clinical performance or effectiveness;
j) clinical benefit(s);
k) principles of operation or mechanism of action, if known;
l) risks (related to the device use and clinical procedure(s), as applicable);
m) any additional clinically relevant claims;
n) if applicable, evaluation of comparability (see 7.5);
o) if applicable, how the DUE addresses an unmet clinical need;
p) intended users and use environment;
q) intended lifetime of the DUE;
r) evaluation criteria for safety and clinical performance or effectiveness, including clinical benefit(s).

ISO/DIS 18969:2025(en)
NOTE 1 The above terminology can differ in meaning depending on the national regulations.
Through cross functional collaboration, clinical evaluation supports the design and development process by
providing the necessary clinical input as follows:
— describe the clinical condition and clinical background;
— identify relevant similar devices and other medical and non-medical alternatives for the target patient
population including their respective limitations (7.2);
— identify reported risks of relevant medical and non-medical alternatives;
— identify and, where possible, quantify clinical benefit(s) from relevant medical and non-medical
alternatives;
— define the clinical outcome parameters and evaluation criteria for the safety and clinical performance or
effectiveness, including clinical benefit(s) to be evaluated, as applicable.
NOTE 2 If the DUE is intended for several distinct indications, where practical, clinical outcomes can be stratified to
demonstrate safety and clinical performance or effectiveness, including clinical benefit(s) per indication.
— relevant information on clinical investigation design as an input for clinical investigations where required
in accordance with ISO 14155:2020, 6.3.
Searches for, and analysis of available knowledge shall be performed to describe the above and, where
applicable, establish specific clinical outcome parameters, and their evaluation criteria. These clinical
outcome parameters shall be used to define intended clinical performance or effectiveness, including clinical
benefits as well as the safety and acceptability of benefit-risk profile of the DUE.
There can be multiple clinical outcome parameters applicable to demonstrate that an individual objective
for safety and clinical performance or effectiveness including clinical benefit(s) has been met.
The above elements are possibly not all available at the same time, hence several searches and analyses of
availabl
...