EN ISO 14155:2020
(Main)Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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 14155:2020)
Dieses Dokument legt die Gute Klinische Praxis für das Design, die Durchführung, Aufzeichnung und Berichterstattung klinischer Prüfungen von Medizinprodukten an menschlichen Prüfungsteilnehmern fest, um die klinische Leistungsfähigkeit oder Wirksamkeit und Sicherheit zu bewerten.
Für klinische Untersuchungen nach dem Inverkehrbringen sollen die in diesem Dokument dargelegten Grundsätze unter Berücksichtigung der Art der klinischen Prüfung, soweit relevant, befolgt werden (siehe Anhang I).
Dieses Dokument legt allgemeine Anforderungen fest, mit denen Folgendes erreicht werden soll:
- der Schutz der Rechte, Sicherheit und des Wohlbefindens der beteiligten Prüfungsteilnehmer;
- die Sicherstellung der wissenschaftlich korrekten Durchführung der klinischen Prüfung und der Glaubwürdigkeit der Ergebnisse der klinischen Prüfung;
- die Festlegung der Verantwortlichkeiten des Sponsors und Hauptprüfers;
- die Unterstützung der Arbeit von Sponsoren, Prüfern, Ethik-Kommissionen, Aufsichtsbehörden und anderen am Konformitätsbewertungsverfahren für Medizinprodukte beteiligten Institutionen.
ANMERKUNG 1 Anwender dieses Dokuments haben zu berücksichtigen, ob noch weitere Normen und/oder nationale Anforderungen auf das jeweils zu beurteilende Prüfprodukt oder die klinische Prüfung anwendbar sind. Liegen Unterschiede zwischen den Anforderungen vor, gelten die strengsten.
ANMERKUNG 2 Bei Software als Medizinprodukt (SaMD) gelten für die Demonstration der analytischen Validität (die Ausgabewerte der SaMD sind für vorgegebene Eingabewerte korrekt) und falls angemessen, die wissenschaftlichen Validität (die Ausgabewerte der SaMD sind mit dem beabsichtigten klinischen Zustand/des beabsichtigten physiologischen Zustands assoziiert) sowie die klinische Leistungsfähigkeit (die Ausgabewerte der SaMD stehen in einem klinisch sinnvollen Zusammenhang mit der zweckbestimmten Nutzung) der SaMD die Anforderungen dieses Dokuments, soweit sie relevant sind (siehe Literaturhinweis [4]). Als Rechtfertigung für eine Befreiung von den Anforderungen dieses Dokuments kann die Einzigartigkeit des indirekten Kontakts zwischen den Prüfungsteilnehmern und der SaMD in Erwägung gezogen werden.
Dieses Dokument gilt nicht für Medizinprodukte für die In-vitro-Diagnostik. Es kann jedoch, in Abhängigkeit vom Produkt und nationalen oder regionalen Anforderungen, Situationen geben, in denen Anwender dieses Dokuments in Erwägung ziehen könnten, ob bestimmte Abschnitte und/oder Anforderungen dieses Dokuments anwendbar sein könnten.
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique clinique (ISO 14155:2020)
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 14155:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2020
Nadomešča:
SIST EN ISO 14155:2011/AC:2011
SIST EN ISO 14155:2012
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse (ISO
14155:2020)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO
14155:2020)
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO
14155:2020)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique
clinique (ISO 14155:2020)
Ta slovenski standard je istoveten z: EN ISO 14155:2020
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
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 14155:2011
English Version
Clinical investigation of medical devices for human
subjects - Good clinical practice (ISO 14155:2020)
Investigation clinique des dispositifs médicaux pour Klinische Prüfung von Medizinprodukten an Menschen
sujets humains - Bonne pratique clinique (ISO - Gute klinische Praxis (ISO 14155:2020)
14155:2020)
This European Standard was approved by CEN on 2 May 2020.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7
European foreword
This document (EN ISO 14155:2020) has been prepared by Technical Committee ISO/TC 194
"Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of 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 February 2021, and conflicting national standards
shall be withdrawn at the latest by February 2021.
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 supersedes EN ISO 14155:2011.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZA and ZB, which is an integral part of
this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this document ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between undated normative references and dated EN and ISO standards
Equivalent dated standard
Normative references as listed
in Clause 2 of the ISO standard
EN ISO or IEC
ISO 14971 EN ISO 14971:2020 ISO 14971:2019
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14155:2020 has been approved by CEN as EN ISO 14155:2020 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/295
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 essential requirements
of that Directive and associated EFTA regulations.
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 Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
For all requirements related to clinical investigations contained in the regulation and referred to in the
following table: obligations attributed to the "sponsor" under ISO 14155 shall be incumbent under the
Directive 93/42/EEC to the manufacturer if located in the EU/EEA/Turkey/Switzerland, and incumbent
to the Authorized Representative otherwise. Both may refer to external service providers in order to
fulfil their obligations.
Table ZA.1 — Correspondence between this European Standard and
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of
Remarks/Notes
Directive 93/42/EEC this EN
Partial fulfilment of the ER, as
regards
1) the documentation of clinical
investigations of medical
Annex I, 6a Entire standard
devices used in the clinical
evaluation process as referred
a
to in Annex X.1.1 and
parts of Annex X.2 listed below.
ISO 14155 does not refer to a
particular version of the declaration
of Helsinki. The latest available
version of the declaration of
Helsinki must be taken into account.
Annex X, 2.2 4, 5, 6.2, 6.3 and 8.4
National/regional requirements for
ethics in clinical research and for
protecting the safety, wellbeing,
health and rights of subjects must
be observed.
Annex X, 2.3.1 6.2, 6,3, 6.4, A.4, A.5, A.6 and A.7
Annex X, 2.3.2 6.3, 6.4, A.2 i), A.3, A.4, A.5 and A.6
Covered provided that the
investigation site’s facilities are
Annex X, 2.3.3 6.3, 6.8, 7.3, 10.2, 10.3and A.6 similar to the facilities required for
the intended use of the
investigational device.
6.2, 6.3, 7.4, 9.2.5, 10.8, A.3, A.4, A.5,
Annex X, 2.3.4
A.6 and A.7
Annex X, 2.3.5 7.4, 9.2.5 and 10.8
6.5, 6.8, 9.2.1, 10.2, 10.3 and
Annex X, 2.3.6
Annex B
Annex X, 2.3.7 8.4, 9.2.6, 10.6 r) and Annex D
a
See MEDDEV 2.7/1, Section 6.3.
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 products falling within the scope of
this standard.
Annex ZB
(informative)
Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/295
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 90/385/EEC of 20 June
1990 on the approximation of the laws of the Member States relating to active implantable medical
devices [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
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 Directive 90/385/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZB is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
For all requirements related to clinical investigations contained in the regulation and referred to in the
following table: obligations attributed to the "sponsor" under ISO 14155 shall be incumbent under the
Directive 90/385/EEC to the manufacturer if located in the EU/EEA/Turkey/Switzerland, and
incumbent to the Authorized Representative otherwise. Both may refer to external service providers in
order to fulfil their obligations.
Table ZB.1 — Correspondence between this European Standard and
Annex I of Directive 90/385/EEC [OJ L 189]
Essential Requirements of Clause(s)/sub-clause(s) of
Remarks/Notes
Directive 90/385/EEC this EN
Partial fulfilment of the ER, as
regards
1) the documentation of clinical
investigations of medical
5 a Entire standard
devices used in the clinical
evaluation process as referred
a
to in Annex VII.1.1 and
parts of Annex VII.2 listed below.
ISO 14155 does not refer to a
particular version of the declaration
of Helsinki. The latest available
version of the declaration of
Helsinki must be taken into account.
Annex 7, 2.2 4, 5, 6.2, 6.3 and 8.4
National/regional requirements for
ethics in clinical research and for
protecting the safety, wellbeing,
health and rights of subjects must
be observed.
Annex 7, 2.3.1 6.2, 6,3, 6.4 and Annex A
Annex 7, 2.3.2 6.3, 6.4, A.2 i)and A.3 to A.6
Covered provided that the
investigation site’s facilities are
Annex 7, 2.3.3 6.3, 6.8, 7.3, 10.2, 10.3 and A.6 similar to the facilities required for
the intended use of the
investigational device.
6.2, 6.3, 7.4, 9.2.5, 10.8 and A.3 to
Annex 7, 2.3.4
A.7
Annex 7, 2.3.5 7.4, 9.2.5 and 10.8
6.5, 6.8, 9.2.1, 10.2, 10.3 and
Annex 7, 2.3.6
Annex B
Annex 7, 2.3.7 8.4, 9.2.6, 10.6 r) and Annex D
a
See MEDDEV 2.7/1, Section 6.3.
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
...
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