FprEN ISO 14155

SLOVENSKI STANDARD
oSIST prEN ISO 14155:2024
01-september-2024
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse
(ISO/DIS 14155:2024)
Clinical investigation of medical devices for human subjects - Good clinical practice
(ISO/DIS 14155:2024)
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO/DIS
14155:2024)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique
clinique (ISO/DIS 14155:2024)
Ta slovenski standard je istoveten z: prEN ISO 14155
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 14155:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 14155:2024
oSIST prEN ISO 14155:2024
DRAFT
International
Standard
ISO/DIS 14155
ISO/TC 194
Clinical investigation of medical
Secretariat: DIN
devices for human subjects — Good
Voting begins on:
clinical practice
2024-06-20
Investigation clinique des dispositifs médicaux pour sujets
Voting terminates on:
humains — Bonne pratique clinique
2024-09-12
ICS: 11.100.20
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
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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 14155:2024(en)
oSIST prEN ISO 14155:2024
DRAFT
ISO/DIS 14155:2024(en)
International
Standard
ISO/DIS 14155
ISO/TC 194
Clinical investigation of medical
Secretariat: DIN
devices for human subjects — Good
Voting begins on:
clinical practice
Investigation clinique des dispositifs médicaux pour sujets
Voting terminates on:
humains — Bonne pratique clinique
ICS: 11.100.20
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 2024
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
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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
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PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 14155:2024(en)
ii
oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
Contents Page
Foreword .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Summary of good clinical practice (GCP) principles . 9
5 Ethical considerations . 10
5.1 General .10
5.2 Improper influence or inducement .10
5.3 Compensation and additional health care .10
5.4 Registration in publicly accessible database .10
5.5 Responsibilities .10
5.6 Communication with the ethics committee (EC) .11
5.6.1 General .11
5.6.2 Initial EC submission .11
5.6.3 Information to be obtained from the EC .11
5.6.4 Continuing communication with the EC . .11
5.6.5 Continuing information to be obtained from the EC . 12
5.7 Vulnerable populations . 12
5.8 Informed consent . 12
5.8.1 General . 12
5.8.2 Process of obtaining informed consent . 13
5.8.3 Special circumstances for informed consent . 13
5.8.4 Information to be provided to the subject .14
5.8.5 Informed consent signature .16
5.8.6 New information.17
6 Clinical investigation planning . 17
6.1 General .17
6.2 Risk management .17
6.2.1 General .17
6.2.2 Risks related to the use of the investigational device and their disclosure .17
6.2.3 Clinical investigation process .18
6.3 Justification for the design of the clinical investigation .18
6.4 Clinical investigation plan (CIP).19
6.5 Investigator's brochure (IB) .19
6.6 Case report forms (CRFs) .19
6.7 Monitoring plan . 20
6.8 Investigation site selection .21
6.9 Agreement(s) .21
6.10 Labelling .21
6.11 Data monitoring committee (DMC) .21
6.12 Clinical events committee (CEC) .21
7 Clinical investigation conduct .22
7.1 General . 22
7.2 Investigation site initiation . 22
7.3 Investigation site monitoring . 22
7.4 Adverse events and device deficiencies . 22
7.4.1 Signals requiring immediate action . 22
7.4.2 Adverse events . 23
7.4.3 Device deficiencies . 23
7.4.4 Risk assessment process for potentially unacceptable risks related to the use of
the investigational device . 23
7.4.5 Management of risks related to clinical procedures required by the CIP .24
7.5 Clinical investigation documents and documentation .24

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oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
7.5.1 Amendments .24
7.5.2 Subject identification log . 25
7.5.3 Source documents . 25
7.6 Additional members of the investigation site team. 25
7.7 Subject privacy and confidentiality of data . 25
7.8 Document and data control . 25
7.8.1 Traceability of documents and data . 25
7.8.2 Recording of data . 26
7.8.3 Electronic clinical data systems . 26
7.9 Investigational device accountability .27
7.10 Accounting for subjects .27
7.11 Auditing .27
8 Suspension, termination, and close-out of the clinical investigation .28
8.1 Completion of the clinical investigation. 28
8.2 Suspension or premature termination of the clinical investigation . 28
8.2.1 General . 28
8.2.2 Suspension . 29
8.2.3 Procedure for premature termination . 29
8.2.4 Procedure for resuming the clinical investigation after suspension . 29
8.3 Routine close-out . 30
8.4 Clinical investigation report. 30
8.5 Risk assessment and conclusions .31
8.6 Document retention .31
9 Responsibilities of the sponsor .31
9.1 Clinical quality management .31
9.2 Clinical investigation planning and conduct .32
9.2.1 Selection and training of clinical personnel.32
9.2.2 Preparation of documents and materials. 33
9.2.3 Conduct of clinical investigation . 33
9.2.4 Monitoring . 34
9.2.5 Safety evaluation and reporting . 36
9.2.6 Clinical investigation close-out .37
9.3 Outsourcing of duties and functions .37
9.4 Communication with regulatory authorities . 38
10 Responsibilities of the principal investigator .38
10.1 General . 38
10.2 Qualification of the principal investigator . 38
10.3 Qualification of investigation site. 39
10.4 Communication with the EC . 39
10.5 Informed consent process . 39
10.6 Compliance with the CIP . 39
10.7 Medical care of subjects . 40
10.8 Safety reporting .41
Annex A (normative) Clinical investigation plan (CIP) .42
Annex B (normative) Investigator's brochure (IB) .50
Annex C (informative) Case report forms (CRFs) .53
Annex D (normative) Clinical investigation report .55
Annex E (informative) Essential clinical investigation documents .60
Annex F (informative) Adverse event categorization. 67
Annex G (informative) EC responsibilities .69
Annex H (informative) Application of ISO 14971 during clinical investigations .73
Annex I (informative) Clinical development stages . 74
Annex J (informative) Clinical investigation audits .79

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Annex K (informative) Clinical investigation design considerations.82
Annex ZA (informative) Relationship between this European standard and the requirements
of Regulation (EU) 2017/745 aimed to be covered .84
Bibliography .91

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oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(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).
This fourth edition cancels and replaces the third edition (ISO 14155:2020), which has been technically
revised. The main changes to the previous edition are as follows:
— Change in definition of clinical performance (3.12);
— Clarification about deviations from eligibility criteria not being permitted but subject to CIP amendment
(see 5.6.4);
— Clarified informed consent to be obtained where applicable from subject’s legally designated
representative (see 5.8.1);
— Clarified subject must be given opportunity to discuss participation with others e.g. family members
(see 5.8.2);
— Clarification on risk management clear distinction between risks related to the use of the device and risks
related to the procedures required by the CIP which are not part of normal clinical practice (see 6.2.1);
— Inclusion of required assessment of residual risks including quantified estimation (see 6.2.2);
— Correction of reference to risks related to the use of the investigational device (see 6.2.1, 7.4.4, 8.2
Annex F, Annex H and 3.2);
— Added normative requirements (previously in Annex A) to 6.4;
— Added requirement for data monitoring committee to confirm conditions for suspending or stopping the
clinical investigation (see 6.11);
— Inclusion of new section on clinical events committee (see 3.7, 6.12 and A.14);

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oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
— Clarify situations of reduced adverse events reporting requirements (see 7.4.2);
— Inclusion of management of risks related to clinical procedures required by the CIP (see 7.4.5);
— Clarified process of suspension or premature termination of the clinical investigation also in line with
updated sections 7.4.4 and Figure H.1 (see 8.2);
— Update of procedure section in CIP with methods and timing for assessing, recording and analysing
variables and added requirement for calibration of equipment (see A.6.4);
— Clarified requirements for non-inferiority margins and missing data (see A.7);
— Added requirement to justify absence of DMC involvement (see A.14);
— Added requirement for subject follow up and continued care to include those different from normal
practice (see A.16);
— Clarification on local representative for better harmonisation with national regulatory requirements
(see 9.2.1);
— Include requirement for implant card (see 9.2.2);
— Moved general requirements to clause 6.4 on objective and study design (see A.5);
— Updated adverse events categorization clarifying terminology in updated flowchart F1 (see Annex F);
— Clarification in Annex H in line with 6.2.1 and updated flowchart (see Annex H);
— Inclusion of estimands and their attributes (see, 6.4, A.5, A.6, A.7, new Annex K);
— Inclusion of precautions (see Clause B.5), information on training on the use of investigational device
(see B.2), and in-silico tests (see B.3).
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.

vii
oSIST prEN ISO 14155:2024
oSIST prEN ISO 14155:2024
DRAFT International Standard ISO/DIS 14155:2024(en)
Clinical investigation of medical devices for human
subjects — Good clinical practice
1 Scope
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical
investigations carried out in human subjects to assess the clinical performance or effectiveness and safety
of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed
as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to:
— protect the rights, safety and well-being of human subjects,
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation
results,
— define the responsibilities of the sponsor and principal investigator, and
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in
the conformity assessment of medical devices.
NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply
to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist,
the most stringent apply.
NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output
is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the
intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically
meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant
(see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact
between subjects and the SaMD.This document does not apply to in vitro diagnostic medical devices. However, there
can be situations, dependent on the device and national or regional requirements, where users of this document might
consider whether specific sections and/or requirements of this document could be applicable.
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 14971, 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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
3.1
adverse device effect
ADE
adverse event (3.2) related to the use of an investigational medical device (3.30)
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate instructions for use,
deployment, implantation, installation, or operation, or any malfunction (3.34) of the investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error (3.53) or from intentional misuse of the
investigational medical device.
Note 3 to entry: This includes ‘comparator’ (3.13) if the comparator is a medical device.
3.2
adverse event
AE
untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including
abnormal laboratory findings) in subjects (3.51), users or other persons, whether or not related to the
investigational medical device (3.30) and whether anticipated or unanticipated
Note 1 to entry: This definition includes events related to the investigational medical device or the comparator (3.13).
Note 2 to entry: This definition includes events related to the use of the investigational medical device and the clinical
procedure(s) required by the CIP that are additional to normal clinical practice.
Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of investigational
medical devices or comparators.
3.3
audit
systematic examination of activities and documents related to a clinical investigation (3.9) performed by (an)
independent (3.27) person(s), to determine whether these activities were conducted, and the data recorded,
analysed and accurately reported, according to the CIP, standard operating procedures, this document and
applicable regulatory requirements
3.4
audit trail
documentation that allows reconstruction of the course of events
3.5
blinding
masking
procedure in which one or more parties to the clinical investigation (3.9) are kept unaware of the treatment
assignment(s)
Note 1 to entry: Single blinding usually refers to the subject(s) (3.51) being unaware of the treatment assignment(s).
Double blinding usually refers to the subject(s), investigator(s) (3.31), monitor and, in some cases, centralized assessors
being unaware of the treatment assignment(s).
Note 2 to entry: A clinical investigation is termed ‘observer blind’, if at least the primary endpoint(s) (3.23) is/are
assessed without knowledge of whether an investigational medical device (3.30) or comparator (3.13) has been used to
treat a subject.
3.6
case report form
CRF
set of printed, optical or electronic documents for each subject (3.51) on which information to be reported to
the sponsor (3.50) is recorded, as required by the CIP

oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
3.7
Clinical events committee
CEC
independent committee of clinical experts that can be established by the sponsor to ensure consistent event
assessment across participating centres and mitigate inadequate reporting risks
Note 1 to entry: For the purpose of this document, “central events committee”, ‘’clinical adjudication committee (CAC)‘’,
‘’endpoint adjudication committee (EAC)’’ are synonymous with CEC.
3.8
certified copy
copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated
signature or by generation through a validated process) to have the same information including data that
describe the context, content, and structure, as the original
3.9
clinical investigation
systematic investigation in one or more human subjects (3.51), undertaken to assess the clinical performance
(3.12), effectiveness (3.21) or safety of a medical device (3.35)
Note 1 to entry: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical
investigation”.
3.10
clinical investigation plan
CIP
document that states the rationale, objectives (3.38), design and pre-specified analysis, methodology,
organization, monitoring (3.36), conduct and record-keeping of the clinical investigation (3.9)
Note 1 to entry: For the purpose of this document “protocol” is synonymous with “CIP”. However, protocol has many
different meanings, some not related to clinical investigation, and these can differ from country to country. Therefore,
the term CIP is used in this document.
3.11
clinical investigation report
document describing the design, conduct, statistical analysis and results of a clinical investigation (3.9)
3.12
clinical performance
ability of a medical device (3.35), resulting from any direct or indirect medical effects which stem from its
technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose
as claimed by the manufacturer, thereby leading to a clinical benefit for subject(s) (3.51), when used as
intended by the manufacturer
Note 1 to entry: Clinical performance can be defined under national regulations.
3.13
comparator
medical device (3.35), therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used
in the control group (3.16) in a clinical investigation (3.9)
3.14
computer system
hardware and software (including associated documents, e.g. user manual) that creates, modifies, maintains,
archives, retrieves, or transmits in digital form information related to the conduct of a clinical investigation (3.9)
3.15
contract research organization
CRO
person or organization contracted by the sponsor (3.50) to perform one or more of the sponsor's clinical
investigation-related duties and functions

oSIST prEN ISO 14155:2024
ISO/DIS 14155:2024(en)
3.16
control group
group of subjects (3.51) that receives the comparator (3.13)
Note 1 to entry: A control group may be concurrent or historical, or subjects may serve as their own control.
3.17
coordinating investigator
investigator (3.31) who is appointed by the sponsor (3.50) to assist in coordinating the work in a multicentre
clinical investigation (3.9)
Note 1 to entry: For the purpose of this document, “national investigator” or “global investigator” are synonymous
with “coordinating investigator”.
3.18
data monitoring committee
DMC
independent (3.27) committee that can be established by the sponsor (3.50) to assess, at intervals, the
progress of the clinical investigation (3.9), the safety data or the critical clinical performance (3.12) or
effectiveness (3.21) endpoints (3.23, 3.24) and to recommend to the sponsor whether to continue, suspend,
modify, or stop the clinical investigation
Note 1 to entry: For the purpose of this document, “data and safety monitoring board (DSMB)”, “data and safety
monitoring committee (DSMC)" or "independent data monitoring committee (IDMC)” are synonymous with DMC.
3.19
deviation
instance of failure to follow, intentionally or unintentionally, the requirements of the CIP (3.10)
3.20
device deficiency
inadequacy in the identity, quality, durability, reliability, usability, safety or performance of a medical device
(3.35), including malfunctions (3.34), use errors (3.53), or inadequacy in the information supplied by the
manufacturer including labelling
Note 1 to entry: This definition includes device deficiencies related to the investigational medical device (3.30) or the
comparator (3.13).
3.21
effectiveness
achievement of a clinically meaningful intended result in a defined portion of the target population when
the investigational medical device (3.30) is used within its intended uses and according to its instructions for
use, the investigator’s brochure (3.32) and the CIP (3.10), as determined by documented scientific evidence
3.22
electronic record
combination of text, graphics, data, audio, imaging, or other information in digital form that is created,
modified, maintained, archived, retrieved, or distributed by a computer system (3.14)
EXAMPLE An electronic CRF.
3.23
endpoint
principal indicator(s) used for providing the evidence for clinical performance (3.12), effectiveness
(3.21) or safety in a clinical investigation (3.9)
3.24
endpoint
indicator(s) used for assessing the secondary objectives (3.38) of a clinical investigation (3.9)

oSIST prEN ISO 14155:2024
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3.25
ethics committee
EC
independent (3.27) body whose responsibility it is to review clinical investigations (3.9) in order to protect
the rights, safety, and well-being of human subjects (3.51) participating in a clinical investigation (3.9)
Note 1 to entry: For the purposes of this document, “ethics committee” is synonymous with “research ethics
committee”, “independent ethics committee” or “institutional review board”. The regulatory requirements pertaining
to ethics committees or similar institutions vary by country or region.
3.26
hypothesis
testable statement, derived from the objective (3.38) of the clinical investigation (3.9) to draw a conclusion
about this objective, based on a pre-specified statistical test
Note 1 to entry: The primary hypothesis is formulated based on the pre-defined primary endpoint (3.23) and is usually
used to calculate the sample size.
3.27
independent
not involved in the development of the investigational device or the conduct of a clinical investigation (3.9),
except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest
3.28
informed consent
process by which an individual voluntarily confirms willingness to participate in a particular clinical
investigation (3.9), after having been informed of all aspects of the investigation that are relevant to the
decision to participate
3.29
investigation site
institution or site where the clinical investigation (3.9) is carried out
Note 1 to entry: For the purpose of this document, “investigation site” is synonymous with “investigation centre”.
3.30
investigational medical device
medical device (3.35) being assessed for safety, clinical performance (3.12)or effectiveness (3.21)in a clinical
investigation (3.9)
Note 1 to entry: This includes medical devices already on the market that are being evaluated for new intended uses,
new populations, new materials or design changes.
Note 2 to entry: This includes medical devices already on the market that are being evaluated within their intended
use in a post-market clinical investigation (interventional or non-interventional).
Note 3 to entry: For the purpose of this document, the terms “investigational medical device” and “investigational
device” are used interchangeably.
3.31
investigator
individual member of the investigation site (3.29) team designated and supervised by the principal
investigator (3.40) at an investigation site to perform clinical investigation-related procedures or to make
important
...