prEN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)

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 [4]). 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.

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)

Le présent document traite des bonnes pratiques cliniques pour la conception, la conduite, l'enregistrement et l'établissement des rapports relatifs aux investigations cliniques menées sur des sujets humains en vue d'évaluer la performance clinique, l'efficacité ou la sécurité des dispositifs médicaux.
Dans le cadre des investigations cliniques après mise sur le marché, les principes définis dans le présent document sont destinés à être appliqués, le cas échéant, en prenant en compte la nature de l'investigation clinique (voir Annexe I).
Le présent document spécifie les exigences générales pour:
— protéger les droits, la sécurité et le bien-être des sujets humains;
— assurer la conduite scientifique de l'investigation clinique et la crédibilité des résultats de l'investigation;
— définir les responsabilités du promoteur et de l'investigateur principal; et
— aider les promoteurs, les investigateurs, les comités d'éthique, les autorités réglementaires et les autres organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux.
NOTE 1 Les utilisateurs du présent document doivent estimer si d'autres normes et/ou exigences nationales peuvent également s'appliquer au(x) dispositif(s) sous investigation ou à l'investigation clinique. Si différentes exigences existent, la plus stricte s'applique.
NOTE 2 Pour les logiciels constituant des dispositifs médicaux (Software as a Medical Device ou SaMD), la démonstration de la validité analytique (le SaMD donne un résultat exact pour une entrée donnée), de la validité scientifique quand elle s'applique (le résultat du SaMD est associé à l'état clinique/physiologique attendu) et de la performances clinique (le résultat du SaMD a un lien cliniquement significatif avec l'utilisation cible) sont couvertes par les exigences du présent document le cas échéant (voir Référence [4]). Des dérogations au présent document peuvent être justifiées par la spécificité du contact indirect entre les sujets et le SaMD.
Le présent document ne s'applique pas aux dispositifs médicaux de diagnostic in vitro. Toutefois, dans certaines situations, en fonction du dispositif et des exigences nationales ou régionales, les utilisateurs du présent document peuvent déterminer si des sections et/ou exigences spécifiques du présent document sont applicables ou non.

Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse (ISO/DIS 14155:2024)

General Information

• Status: Not Published
• Publication Date: 12-Jan-2026
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 20-Jun-2024
• Completion Date: 20-Jun-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 14155:2024 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)

Relations

• Revises: EN ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• Effective Date: 21-Dec-2022

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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 14155:2024(en)
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
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 14155:2024(en)
ii
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

iii
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.
...