ISO/TR 12417-2:2022

TECHNICAL ISO/TR
REPORT 12417-2
Second edition
2022-07
Cardiovascular implants and
extracorporeal systems — Vascular
device-drug combination products —
Part 2:
Local regulatory information
Implants cardiovasculaires et circuits extra-corporels — Produits de
combinaison médicament-dispositif vasculaire —
Partie 2: Directives règlementaires locales
Reference number
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Information on device- and drug-related aspects — Applicable documents for local
guidance . 4
4.1 General . 4
4.2 Australia . 4
4.2.1 General . 4
4.2.2 Australia: Managing changes . 5
4.2.3 Australia: Clinical evaluation requirements . 5
4.2.4 Australia: Audit requirements . 5
4.3 Brazil . 5
4.3.1 Brazil: Managing changes . 5
4.3.2 Brazil: Clinical evaluation requirements . 6
4.3.3 Brazil: Audit requirements. 6
4.4 Canada . 6
4.4.1 Canada: Managing changes . 6
4.4.2 Canada: Clinical evaluation requirements . 6
4.4.3 Canada: Audit requirements . 6
4.5 European Union (EU). 6
4.5.1 EU: Managing changes . 6
4.5.2 EU: Material inclusion and labelling requirements . 7
4.5.3 EU: Clinical evaluation requirements . 7
4.5.4 EU: Audit requirements . 7
4.6 India . 7
4.6.1 India: Managing changes . . 7
4.6.2 India: Clinical evaluation requirements . 8
4.6.3 India: Audit requirements . 8
4.7 Japan . 8
4.7.1 Japan: Managing changes. 8
4.7.2 Japan: Clinical evaluation requirements . 8
4.7.3 Japan: Audit requirements . 8
4.8 People's Republic of China (PRC) . 8
4.8.1 PRC: Managing changes . . 8
4.8.2 PRC: Clinical evaluation requirements . 9
4.8.3 PRC: Audit requirements . 10
4.9 Russia . 10
4.9.1 Russia: Managing changes . 10
4.9.2 Russia: Clinical evaluation requirements . 10
4.9.3 Russia: Audit requirements . 10
4.10 United States of America (USA) . 10
4.10.1 USA: Managing changes . 10
4.10.2 USA: Clinical evaluation requirements. 11
4.10.3 USA: Audit requirements . 11
5 Managing changes that can impact the DCP .12
5.1 General .12
5.2 Change evaluation .12
5.2.1 Identify changes .12
5.2.2 Risk evaluation.13
5.2.3 Guidance for change evaluation . 13
iii
5.2.4 Pre-market . 14
5.3 Interactions with region-specific regulatory authorities — Post-commercialization . 14
Bibliography .22
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO/TR 12417-2:2017), which has been
technically revised.
The main changes are: editorial changes have been made regarding the use of requirements,
recommendations, permissions and possibilities.
A list of all parts in the ISO 12417 series can be found on the ISO website.
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
Introduction
This document was prepared in order to provide local regulatory information for vascular device-drug
combination products (VDDCPs).
VDDCPs are medical devices with various clinical indications for use in the human vascular blood
system. A VDDCP incorporates, as an integral part, substance(s) which, if in final formulation separately,
can be considered to be a medicinal product (drug product) but the action of the medicinal substance is
ancillary to that of the device and supports the primary mode of action of the device.
Only regulatory issues related to drug(s) combined with the vascular device based on the ancillary
function of the VDDCP are covered by this document.
Although this document attempts to represent the state-of-the-art regarding regulatory requirements
for pre and post-approval changes, these requirements are evolving and as such
...