Edition date:	2026-04-22 In Force
Available languages:	French, English
Summary:	This document specifies good clinical practice (GCP) 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 the general requirements intended to protect the rights, safety and well-being of human subjects, users or other persons, 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. Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s). NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), 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 [5]). 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 can consider whether either specific sections or requirements of this document, or both, can be applicable. 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 les 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, dans la mesure du possible, 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, utilisateurs ou autres personnes; assurer une 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 assister 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. D'autres normes ou exigences nationales peuvent également s'appliquer au(x) dispositif(s) sous investigation ou à l'investigation clinique. NOTE Pour les logiciels constituant des dispositifs médicaux (Software as a Medical Device ou SaMD), si applicable, la démonstration de la validité analytique (le SaMD donne un résultat exact pour une entrée donnée), de la validité scientifique (le résultat du SaMD est associé à l'état clinique/physiologique attendu) et de la performance clinique (le résultat du SaMD a un lien cliniquement significatif avec l'utilisation cible) est couverte par les exigences du présent document autant qu'applicable (voir Référence [5]). 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 ou si des exigences spécifiques du présent document, peuvent être applicables, voire les deux. Dieses Dokument legt die Gute Klinische Praxis (GCP, en: good clinical practice) 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 Nachbeobachtung 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 die allgemeinen Anforderungen fest, mit denen Folgendes erreicht werden soll:  der Schutz der Rechte, Sicherheit und des Wohlbefindens der beteiligten Prüfungsteilnehmer, Anwender oder anderer Personen;  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. Weitere Normen oder nationale Anforderungen auf das/die jeweils zu beurteilende(n) Prüfprodukt(e) oder die klinische(n) Prüfung(en) können anwendbar sein. ANMERKUNG Bei Software als Medizinprodukt (SaMD) gelten gegebenenfalls für die Demonstration der analytischen Validität (die Ausgabewerte der SaMD sind für vorgegebene Eingabewerte korrekt) und der wissenschaftlichen Validität (die Ausgabewerte der SaMD sind mit dem beabsichtigten klinischen Zustand/des beabsichtigten physiologischen Zustands assoziiert) sowie der klinischen 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 [5]). 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 ist nicht für Medizinprodukte für die In-vitro-Diagnostik anwendbar. Es kann jedoch, in Abhängigkeit vom Produkt und nationalen oder regionalen Anforderungen, Situationen geben, in denen Anwender dieses Dokuments in Erwägung ziehen können, ob entweder bestimmte Abschnitte oder Anforderungen dieses Dokuments, oder beides, anwendbar sein können.
ICS:	11.100.20-Biological evaluation of medical devices
CTN:	CEN/TC 206 - 6187
Otras Relaciones	Acuerdo de Viena ISO 14155:2026
Reemplazo Normas	Reemplaza a EN ISO 14155:2020 Reemplaza a EN ISO 14155:2020/A11:2024

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EN ISO 14155:2026

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