EN ISO 14155:2020/A11:2024
(Amendment)Clinical investigation of medical devices for human subjects - Good clinical practice
Clinical investigation of medical devices for human subjects - Good clinical practice
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 AnnexI).
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.
NOTE1 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.
NOTE2 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, whereusers 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
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique clinique
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse - Dopolnilo A11
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2025
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse -
Dopolnilo A11
Clinical investigation of medical devices for human subjects - Good clinical practice
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique
clinique
Ta slovenski standard je istoveten z: EN ISO 14155:2020/A11:2024
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.
EN ISO 14155:2020/A11
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 11.100.20
English Version
Clinical investigation of medical devices for human
subjects - Good clinical practice
Investigation clinique des dispositifs médicaux pour Klinische Prüfung von Medizinprodukten an Menschen
sujets humains - Bonne pratique clinique - Gute klinische Praxis
This amendment A11 modifies the European Standard EN ISO 14155:2020; it was approved by CEN on 27 November 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155:2020/A11:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 14155:2020/A11:2024) has been prepared by Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices”, the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 14155:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2025, and
conflicting national standards shall be withdrawn at the latest by June 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document amends EN ISO 14155:2020 with a revised European Foreword and the European
Annex ZA.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
Annex ZA
(informative)
Relationship between this European standard and the requirements of
Regulation (EU) 2017/745 aimed to be covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to Annex XV of Regulation (EU) 2017/745 of 5 April 2017 concerning clinical
investigations of medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding requirements of that
Regulation, and associated EFTA Regulations.
This Annex ZA covers the relationship of this European standard with Annex XV of Regulation (EU)
2017/747 (Table ZA.1). Where requirements laid down in that Annex XV refer to Article 62 of this
Regulation, the related requirements laid down in the section of Article 62 cited have also been
considered when establishing the relationship of the clauses of this European standard with Annex XV
in Table ZA.1.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the difference is indicated in Table ZA.3. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out
in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
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 the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far
as possible’, or ‘minimized’, according to the wording of the corresponding General Safety 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.
For all requirements related to clinical investigations contained in Regulation (EU) 2017/47 and
referred to in the following table, obligations attributed to the "sponsor" under ISO 14155 shall be
incumbent under the Regulation to the Sponsor if located in the Union; When established, the Legal
Representative is responsible for ensuring compliance with the sponsor’s obligations pursuant to
Regulation (EU) 2017/745.
Table ZA.1 — Correspondence between this European Standard and Annex XV
of Regulation (EU) 2017/745 [OJ L 117]
Clinical Investigation
Clause(s)/subclause(s) of
Requirements of Regulation Remarks/Notes
this EN
(EU) 2017/745
Covered by a general reference to
the Declaration of Helsinki;
however, the latest edition of the
Declaration should be used.
Annex XV, Chapter I, 1 4 a) National/regional requirements for
ethics in clinical research and for
protecting the safety, wellbeing,
health and rights of subjects must
be observed.
6.2 of this document covers risk
management considerations of
both the investigational device as
well as the procedures required by
the clinical investigation plan that
are outside standard of care.
6.3 of this document refers to the
literature review of the standard of
care as a basis to define the
appropriate study design as well as
the requirement to take into
consideration and relevant pre-
Annex XV, Chapter I, 2.1 6.2, 6.3, 6.4, 7.4.4, and Annex A
clinical data.
6.4 of this document combined
with Annex A provides a detailed
outline on the study design and
statistical considerations required
to obtain scientific valid data on
safety, performance and clinical
benefits.
7.4.4 of this document covers the
risk assessment process for
potentially unacceptable risks.
6.3, 6.4, A.2 i), A.3, A.4, A.5, A.6
Annex XV, Chapter I, 2.2
and A.7
Annex XV, Chapter I, 2.3 6.3, 6.4, A.3, A.4, A.5, A.6 and A.7
Partially covered - this document
does not cover the requirements of
the clinical evaluation plan as this
6.3, 6.4, 6.8, 9.2.1 b) to e), 10.2, is not part of the clinical
Annex XV, Chapter I, 2.4
10.3, A.2 h), A.3, A.6, and A.7 investigation. However, 6.3 does
refer to the appropriate literature
review required prior to designing
a clinical investigation.
Clinical Investigation
Clause(s)/subclause(s) of
Requirements of Regulation Remarks/Notes
this EN
(EU) 2017/745
6.2, 6.3, A.2 e), f) and g), A.3,
Annex XV, Chapter I, 2.5
A.4, A.6, A.7 and B.2
Annex XV, Chapter I, 2.6 6.3, A.6 and A.7
6.5, 9.2.1 g), 9.2.2, 10.2, A.2 h)
Annex XV, Chapter I, 2.7
and Annex B
Annex XV, Chapter I, 2.8 8.4, 9.2.6, 10.6 r) and Annex D
Annex XV, Chapter II, 2.1 B.2, B.4 a)
Annex XV, Chapter II, 2.2 B.2 f) and g)
Annex XV, Chapter II, 2.3 B.3
Annex XV, Chapter II, 2.4 B.4
Partially covered – this document
requires a prior assessment of
relevant scientific literature but
does not specifically require its
incorporation into the
Investigator’s Brochure except for
Annex XV, Chapter II, 2.4,
what is mentioned in B.2 a).
6.3, B.2 a), B.4
first indent
Also, this document requires a
prior assessment of relevant
scientific literature and available
data on the same or similar devices
but is not specific on safety,
performance and clinical benefits.
Partially covered – this document
requires a prior assessment of
relevant scientific literature and
Annex XV, Chapter II, 2.4,
6.3, B.2 a), B.4 a) and b) available data on the same or
second indent
similar devices but is not specific
on safety, performance and clinical
benefits.
Annex XV, Chapter II, 2.5 B.5
Partially covered – this document
does not specifically refer to a
particular regulatory system. The
document does not include the
Annex XV, Chapter II, 2.6 B.2 c)
added value of incorporation of
such constituents in relation to the
clinical benefit and/or safety of the
device.
Annex XV, Chapter II, 2.7 B.6
Annex XV, Chapter II, 3.1.1 A.1.2 b)
Clinical Investigation
Clause(s)/subclause(s) of
Requirements of Regulation Remarks/Notes
this EN
(EU) 2017/745
Partially covered - the document
outlines that, when a local
representative is established, the
local representative acts as the
sponsor fulfilling responsibilities of
Annex XV, Chapter II, 3.1.2 A.1.3
the sponsor, which differs from the
responsibility of the legal
representative outlined in Article
62(2) of Regulation (EU)
2017/745.
Annex XV, Chapter II, 3.1.3 A.1.4
Annex XV, Chapter II, 3.1.4 A.12 f)
Partially covered - in the document
the language used for the synopsis
Annex XV, Chapter II, 3.1.5 A.1.5 is not specified as this is considered
as a country specific regulatory
requirement.
Background literature review and
current state of the art are not
covered as part of the identification
Annex XV, Chapter II, 3.2 6.3, A.2, A.3 a) and b), A.4 a) of the device but as part of the
justification of the design which is
derived from literature review as
outlined in 6.3 of the document.
Annex XV, Chapter II, 3.3 A.4
Annex XV, Chapter II, 3.5 A.5
Annex XV, Chapter II, 3.6 6.3, A.6.1 a) to d), A.7
Annex XV, Chapter II, 3.6.1 A.6.1 a), A.6.1 c)
Annex XV, Chapter II, 3.6.2 A.2 a), A.6.1 a)
To fully cover requirement 3.6.3,
the information provided should
also include immuno-compromised
and elderly subjects, if applicable.
However, clause A.5 of this
Annex XV, Chapter II, 3.6.3 A.5, A.6.3 j), A.15 document does require the study
design to be relevant for the target
population as well as A.6.3 j)
requiring clarification of the
relationship of the investigation
population to the target population.
Annex XV, Chapter II, 3.6.4 A.6.1 b), A.7 i), j) and k)
Annex XV, Chapter II, 3.6.5 A.6.4
Clinical Investigation
Clause(s)/subclause(s) of
Requirements of Regulation Remarks/Notes
this EN
(EU) 2017/745
Annex XV, Chapter II, 3.6.6 A.6.5
Annex XV, Chapter II, 3.7 A.7
Annex XV, Chapter II, 3.8 A.8
Annex XV, Chapter II, 3.9 A.9
Annex XV, Chapter II, 3.10 A.10
Annex XV, Chapter II, 3.11 A.11
Annex XV, Chapter II, 3.12 A.12
Annex XV, Chapter II, 3.13 A.13
Annex XV, Chapter II, 3.14 A.14
Traceability for implantable
Annex XV, Chapter II, 3.15 A.16, A.7 e) 6), A.7 m)
devices is not covered.
To fully cover requirement 3.16,
informa
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.