EN ISO 20916:2024
(Main)In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.
In‑vitro-Diagnostika - Klinische Leistungsstudien unter Verwendung von menschlichem Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019)
Dieses Dokument legt die gute Studienpraxis für die Planung, Design, Durchführung, Aufzeichnung und Meldung klinischer Leistungsstudien fest, die durchgeführt werden, um die klinische Leistungs¬fähigkeit und Sicherheit von In vitro-Diagnostika (IVD) für Zulassungszwecke zu bewerten.
ANMERKUNG 1 Das Ziel dieser Studien ist es, die Fähigkeit eines In vitro-Diagnostikums in den Händen des bestimmungsgemäßen Anwenders zu bewerten, Ergebnisse in Bezug auf eine bestimmte gesundheitliche Verfassung oder einen physiologischen/pathologischen Zustand in der bestimmungsgemäßen Population zu liefern.
Das Dokument soll nicht beschreiben, ob die technischen Spezifikationen des betreffenden In vitro-Diagnostikums durch die klinische Leistungsstudie ausreichend abgedeckt sind.
Dieses Dokument legt die Grundsätze fest, die klinischen Leistungsstudien zugrunde liegen, und gibt allgemeine Anforderungen an, die dazu dienen
sicherzustellen, dass die Durchführung der klinischen Leistungsstudie zu zuverlässigen und soliden Studienergebnissen führen wird,
die Verantwortlichkeiten des Sponsors und Hauptprüfers festzulegen,
die Arbeit von Sponsoren, klinischen Forschungseinrichtungen, Prüfern, Ethik-Kommissionen, Regulierungsbehörden und anderen am Konformitätsbewertungsverfahren für In vitro-Diagnostika beteiligten Institutionen zu unterstützen und
die Rechte, Sicherheit, Würde und das Wohlbefinden der Prüfungsteilnehmer zu schützen, die Untersuchungsmaterial zur Verwendung in klinischen Leistungsstudien bereitstellen.
Analytische Leistungsstudien liegen außerhalb des Anwendungsbereiches dieses Dokuments.
ANMERKUNG 2 Wenn die Entnahme von Untersuchungsmaterial speziell für die analytische Leistungsstudie ein zusätzliches Entnahmerisiko für den Prüfungsteilnehmer darstellt, können einige der Elemente dieses Dokuments (insbesondere die Anhänge) nützlich sein, um die Sicherheit des Prüfungsteilnehmers sicherzustellen.
Klinische Leistungsstudien, die aus anderen Gründen als Zulassungszwecke vor und nach dem Inverkehrbringen durchgeführt werden, z. B. zu Zwecken der Erstattung, fallen nicht in den Anwendungs-bereich dieses Dokuments.
ANMERKUNG 3 Einige der Elemente dieses Dokuments können für das Design solcher Studien nützlich sein, einschließlich der Sicherheit des Prüfungsteilnehmers und der Datenintegrität.
Dieses Dokument enthält keine Sicherheitshinweise für Labormitarbeiter oder anderes Personal, das das Untersuchungsmaterial entnimmt.
ANMERKUNG 4 Diese Informationen sind in anderen Veröffentlichungen [1] [12] [13] enthalten.
ANMERKUNG 5 Anwender dieses Dokuments können in Betracht ziehen, ob andere Normen und/oder Anforderungen auch für das In vitro-Diagnostikum gelten, das Gegenstand der klinischen Leistungsstudie ist, z. B. können in dem Fall, in dem es ein In vitro-Diagnostikum und ein Medizinprodukt gibt, die in einem integrierten System verwendet werden (z. B. eine Lanzette, ein IVD Teststreifen und ein Blutzuckermessgerät), Aspekte sowohl dieses Dokuments als auch von ISO 14155 berücksichtigt werden.
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude (ISO 20916:2019)
Le présent document définit les bonnes pratiques pour la planification, la conception, la conduite, l'enregistrement et l'établissement du rapport d'études des performances cliniques menées en vue d'évaluer les performances cliniques et la sécurité de dispositifs médicaux de diagnostic in vitro (DIV) à des fins réglementaires.
NOTE 1 Ces études visent à évaluer la capacité d'un dispositif médical DIV, mis à disposition de l'utilisateur concerné, à produire des résultats propres à une affection particulière ou à un état physiologique/pathologique particulier, au sein de la population concernée.
Le document n'est pas destiné à décrire si les spécifications techniques du dispositif médical DIV en question sont adéquatement prises en compte ou non par l'étude des performances cliniques.
Le présent document identifie les principes étayant les études des performances cliniques et spécifie les exigences générales visant à
— assurer que la conduite de l'étude des performances cliniques donnera des résultats d'étude fiables et robustes,
— définir les responsabilités du promoteur et de l'investigateur principal,
— aider les promoteurs, les organismes de recherche clinique, les investigateurs, les comités d'éthique, les autorités réglementaires et les autres organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux DIV, et
— protéger les droits, la sécurité, la dignité et le bien-être des sujets fournissant des prélèvements utilisables dans les études des performances cliniques.
Les études des performances analytiques ne font pas partie du domaine d'application du présent document.
NOTE 2 Lorsque la collecte de prélèvements spécifiques à l'étude des performances analytiques crée un risque de collecte supplémentaire pour les sujets, certains des éléments du présent document (en particulier les annexes) peuvent être utiles pour assurer la sécurité du sujet.
Les études des performances cliniques menées à des fins autres que réglementaires pré- et post-commercialisation, notamment dans le cadre d'une demande de remboursement, ne font pas partie du domaine d'application du présent document.
NOTE 3 Certains des éléments du présent document peuvent être utiles pour concevoir ces études, notamment la sécurité du sujet et l'intégrité des données.
Le présent document ne comprend pas d'informations de sécurité pour les personnels de laboratoire ou les autres personnels les prélèvements d'étude.
NOTE 4 Ces informations figurent dans d'autres publications[1][12][13].
NOTE 5 Les utilisateurs du présent document peuvent tenir compte du fait que d'autres normes et/ou exigences s'appliquent également au dispositif médical DIV qui fait l'objet de l'étude des performances cliniques ; par exemple, si un dispositif médical DIV et un dispositif médical sont utilisés dans un système intégré (par exemple, une lancette, une bandelette réactive DIV et un glucomètre), les aspects du présent document et de l'ISO 14155 peuvent être pris en considération.
Diagnostični medicinski pripomočki in vitro - Klinične študije učinkovitosti z uporabo človeških vzorcev - Dobre študijske prakse (ISO 20916:2019)
Ta dokument določa dobro študijsko prakso za načrtovanje, izvajanje, beleženje in poročanje o študijah klinične učinkovitosti, izvedenih za ocenjevanje klinične učinkovitosti in varnosti diagnostičnih medicinskih pripomočkov in vitro (IVD) za regulativne namene.
OPOMBA 1: Namen teh študij je oceniti sposobnost medicinskega pripomočka in vitro, ki ga uporablja predvideni uporabnik, da zagotovi rezultate, ki se nanašajo na posebno zdravstveno stanje ali fiziološko/patološko stanje ciljne populacije.
Dokument ni namenjen opisovanju, ali so tehnične specifikacije medicinskega pripomočka in vitro ustrezno obravnavane v študiji klinične učinkovitosti.
Ta dokument opredeljuje načela, na katerih temeljijo študije klinične učinkovitosti, in določa splošne zahteve za
– zagotavljanje, da bo izvedba študije klinične učinkovitosti dala zanesljive rezultate,
– opredelitev odgovornosti sponzorja in glavnega preiskovalca,
– pomoč sponzorjem, organizaciji za klinične raziskave, preiskovalcem, odborom za etiko, regulativnim organom in drugim organom, ki so vključeni v oceno skladnosti medicinskih pripomočkov in vitro, in
– zaščito pravic, varnosti, dostojanstva in dobrega počutja subjektov, ki zagotavljajo vzorce za uporabo v študijah klinične učinkovitosti.
Študije analitične učinkovitosti ne spadajo v področje uporabe tega dokumenta.
OPOMBA 2: Če zbiranje vzorcev posebej za študijo analitične učinkovitosti ustvarja dodatno tveganje pri zbiranju za subjekte, so lahko nekateri elementi tega dokumenta (predvsem dodatki) uporabni za zagotavljanje varnosti subjekta.
Študije klinične učinkovitosti, ki niso izvedene zaradi regulativnih namenov pred dajanjem in po dajanju na trg, na primer za namene povračila, niso zajete v področje uporabe tega dokumenta.
OPOMBA 3: Nekateri elementi tega dokumenta so lahko uporabni pri snovanju tovrstnih študij, vključno z varnostjo subjekta in celovitostjo podatkov.
Ta dokument ne vključuje informacij o varnosti za laboratorijske delavce ali drugo osebje, ki zbira vzorce za študijo.
OPOMBA 4: Te informacije so zajete v druge publikacije [1][12][13].
OPOMBA 5: Uporabniki tega dokumenta lahko preučijo, ali tudi drugi standardi in/ali zahteve veljajo za medicinski pripomoček in vitro, ki je predmet študije klinične učinkovitosti, na primer v primeru, ki vključuje medicinski pripomoček in vitro in medicinski pripomoček v integriranem sistemu (npr. lanceta, preskusni trak in vitro in merilec krvnega sladkorja), se lahko upošteva vidike iz tega dokumenta in standarda ISO 14155.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2024
Diagnostični medicinski pripomočki in vitro - Klinične študije učinkovitosti z
uporabo človeških vzorcev - Dobre študijske prakse (ISO 20916:2019)
In vitro diagnostic medical devices - Clinical performance studies using specimens from
human subjects - Good study practice (ISO 20916:2019)
In-vitro-Diagnostika - Klinische Leistungsuntersuchungen an menschlichem
Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019)
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant
des prélèvements de sujets humains - Bonnes pratiques d'étude (ISO 20916:2019)
Ta slovenski standard je istoveten z: EN ISO 20916:2024
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20916
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
ICS 11.100.10
English Version
In vitro diagnostic medical devices - Clinical performance
studies using specimens from human subjects - Good study
practice (ISO 20916:2019)
Dispositifs médicaux de diagnostic in vitro - Études des In-vitro-Diagnostika - Klinische
performances cliniques utilisant des prélèvements de Leistungsuntersuchungen an menschlichem
sujets humains - Bonnes pratiques d'étude (ISO Untersuchungsmaterial - Gute Studienpraxis (ISO
20916:2019) 20916:2019)
This European Standard was approved by CEN on 7 August 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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 20916:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 4
European foreword
The text of ISO 20916:2019 has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory
testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO)
and has been taken over as EN ISO 20916:2024 by Technical Committee CEN/TC 140 “In vitro
diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2024, and conflicting national standards
shall be withdrawn at the latest by March 2027.
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 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.
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.
Endorsement notice
The text of ISO 20916:2019 has been approved by CEN as EN ISO 20916:2024 without any modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of
5 April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
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 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation
(EU) 2017/746, the differences shall be indicated in the Annex ZA. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/746, the definitions set out in
this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
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 In vitro Diagnostic
Regulation (EU) 2017/746.
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) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘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’, ‘prevented’ 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, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/746 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
Clause(s) / sub-
General Safety and
clause(s)
Performance Requirements Remarks / Notes
of Regulation (EU) 2017/746
of this EN
3 (b) C.5 Covered with respect to in vitro
diagnostic medical devices under
clinical performance study
3 (c) C.5 Covered for in vitro diagnostics medical
devices under clinical performance
study with the exemption of the
estimation and evaluation of risks
associated with and during the
“reasonably foreseeable misuse”
4 (c) C.5 Covered with respect to safety
principles and risk control measures
for devices under clinical performance
study except aspects regarding training
to users.
8 B.7 Covered with respect to the benefit-
risk evaluation performed during a
clinical performance study
9.1 (a) 5.3 (i) Covered with respect to the items listed
in 5.3 (i) that are included in the
clinical performance study.
9.1 (b) 5.3 Covered with respect to the items listed
in 5.3 (j) that are included in the
clinical performance study. Expected
values in normal and affected
populations are not covered.
9.4. (a) 5.3 c) 4), 5. 3 g), 5. 3 h) Covered with respect to the items listed
in 5.3 c) 4), 5. 3 g), 5. 3 h) that are
included in the clinical performance
study.
9.4. (b) 5.3 c) 4), 5. 3 g), 5. 3 h) Covered with respect to the items listed
in 5.3 c) 4), 5. 3 g), 5. 3 h) that are
included in the clinical performance
study.
20.2 (e) 5.12 Covered with respect to the labelling of
the in vitro diagnostics medical device
under clinical performance study.
Table ZA.2 – Correspondence between this European standard and Annex XIII of Regulation (EU)
2017/746 [OJ L 117]
Requirements of Regulation Clause(s) / sub-clause(s)
Remarks / Notes
2017/746, Annex XIII (EU) of this EN
2.2 4.1, 4.3, 4.4, 5.5.2 (b), 5.5.2 Covered with respect to ethical
(n), 5.5.3.17, 5.10 (c), 7.3.1 considerations
2.3.1 5.3, B.8.1 c) Covered with respect to the study
design, the items listed in 5.3 that
are included in the clinical
performance study and with respect
to bias minimalization
2.3.2 first and second 5.5.3 Covered with respect to the content
paragraphs of CPSP
2.3.2 (b) 5.5.3.4 Covered with respect to the sponsor
information
2.3.2 (c) 5.9 Covered with respect to study site
identification and qualification if
included in the clinical performance
study
2.3.2 (e) 5.5.3.3, 5.5.3.8 Covered with respect to the
information of the in vitro
diagnostics medical device
2.3.2 (f) 5.5.3.9, 5.7 Covered with respect to the
specimen information
2.3.2 (g) 5.5.3.6 Covered with respect to the
summary of the study; current state
of the art in diagnosis and/or
medicine is not covered.
2.3.2 (o) 5.10 Covered
2.3.3 8.2, Annex D Covered
Table ZA.3 – Correspondence between this European standard and Annex XIV of Regulation (EU)
2017/746 [OJ L 117]
Requirements of Regulation Clause(s) / sub-clause(s)
Remarks / Notes
(EU) 2017/746, Annex XIV of this EN
1.6. 5.3, 5.5.3, Annex B Covered with respect to the design
of the clinical performance study
and the content of the CPSP
1.10. 5.5.3.3 Covered except the classification of
the in vitro diagnostics medical
device
1.11. 5.5.3.6 Covered
1.12. 5.5.3.8 Covered
Requirements of Regulation Clause(s) / sub-clause(s)
Remarks / Notes
(EU) 2017/746, Annex XIV of this EN
1.13. 5.1 3rd paragraph, 6.3 Covered with respect to
qualification evidence of the
investigator and the study site
1.13. 5.9 Covered with respect to the
capability/suitability of the site
1.17. Annex C.6 Covered with respect to the list of
applied standards
2. Annex C Covered with respect to IB
2.5. Annex B.7 and C.5 Covered
2.7. Annex C.6 a) and b) Covered with respect to the list of
applied standards
3. 5.5.3 Covered with respect to the content
of the CPSP
4.2. 6.2 f), Annex E.3 Covered
4.4. 4.5, Annex A.8 2nd Covered with respect to leftover or
paragraphe, Annex E.2 c), archived specimen, compensation,
Annex F.2, Annex F.4, Annex needed translation of the document,
E.3 process for obtaining informed
consent and the provided
information and content of the
informed consent document
4.6. 5.2 Covered with respect to Risk
analysis
Chapter II 1. 7.2 c), 7.2. g) Covered with respect to sponsors
obligations to provide information
to the authorities
Chapter II 2. Annex G Covered with respect to the
categorisation of adverse events
Chapter II 4. 5.10 Covered with respect to the study
monitoring obligations, but not with
respect to the independence of the
monitor
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 20916
First edition
2019-05
In vitro diagnostic medical devices —
Clinical performance studies using
specimens from human subjects —
Good study practice
Dispositifs médicaux de diagnostic in vitro — Études des
performances cliniques utilisant des prélèvements de sujets humains
— Bonnes pratiques d'étude
Reference number
ISO 20916:2019(E)
©
ISO 2019
ISO 20916:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publ
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.