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 (ISO 14155:2020)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique clinique
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse - Dopolnilo A11
Ta dokument obravnava dobre klinične prakse za načrtovanje, izvajanje in beleženje kliničnih raziskav pri ljudeh ter poročanje o njih, s čimer se ocenjujeta klinična učinkovitost oziroma uspešnost in varnost medicinskih pripomočkov.
V kliničnih raziskavah po dajanju na trg je treba upoštevati načela iz tega dokumenta, kolikor so relevantna ob upoštevanju narave klinične raziskave (glej dodatek I).
Ta dokument določa splošne zahteve za:
– zaščito pravic, varnosti in dobrega počutja ljudi;
– zagotavljanje znanstvene izvedbe kliničnih raziskav in verodostojnosti rezultatov;
– opredelitev odgovornosti sponzorja in glavnega raziskovalca; ter
– pomoč sponzorjem, raziskovalcem, odborom za etiko, regulativnim organom in drugim organom, ki so vključeni v oceno skladnosti medicinskih pripomočkov.
OPOMBA 1: Uporabniki tega dokumenta morajo presoditi, ali za obravnavane pripomočke oziroma klinične raziskave veljajo tudi drugi standardi in/ali nacionalne zahteve.
Če se zahteve med seboj razlikujejo, se uporabljajo najstrožje.
OPOMBA 2. Za dokazovanje analitične veljavnosti programske opreme kot medicinskega pripomočka (SaMD) (izhodni podatki programske opreme kot medicinskega pripomočka so ustrezni glede na dane vhodne podatke) ter, kjer je primerno, njene znanstvene veljavnosti (izhodni podatki programske opreme kot medicinskega pripomočka so povezani s predvidenim kliničnim/fiziološkim stanjem) in klinične učinkovitosti (izhodni podatki programske opreme kot medicinskega pripomočka zagotavljajo klinično pomembno povezavo s ciljno uporabo) se uporabljajo zahteve tega dokumenta, kolikor je to ustrezno (glej sklic [4]). Pri utemeljitvah izjem iz tega dokumenta je mogoče upoštevati edinstvenost posrednega stika med subjekti in programsko opremo kot medicinskim pripomočkom.
Ta dokument se ne uporablja za diagnostične medicinske pripomočke in vitro. Vendar pa lahko, odvisno od pripomočka in nacionalnih ali regionalnih zahtev, pride do situacij, v katerih bi uporabniki tega dokumenta lahko presodili, da bi bilo mogoče uporabiti določene razdelke in/ali zahteve iz tega dokumenta.
General Information
Relations
Overview
EN ISO 14155:2020/A11:2024 - Clinical investigation of medical devices for human subjects - Good clinical practice (CEN amendment) sets out good clinical practice (GCP) principles for the design, conduct, recording and reporting of clinical investigations involving human subjects to assess the safety, clinical performance and effectiveness of medical devices. The amendment A11 (approved Nov 2024) updates the European foreword and Annex ZA to clarify the relationship with Regulation (EU) 2017/745 (EU MDR). This standard is not intended for in vitro diagnostics (IVDs), but parts may be relevant depending on national/regional requirements. It also addresses Software as a Medical Device (SaMD) where analytical, scientific validity and clinical performance demonstrations are applicable.
Key topics and requirements
- Protection of human subjects: Principles and practices to protect participants’ rights, safety and well‑being during clinical investigations.
- Scientific conduct and credibility: Requirements to ensure study designs, statistical considerations and reporting produce reliable, scientifically valid results.
- Responsibilities: Clear allocation of duties for the sponsor and principal investigator, including obligations for monitoring, record‑keeping and trial oversight.
- Clinical investigation planning: Expectations for the Clinical Investigation Plan (CIP), literature review, risk assessment and justification of design decisions.
- Risk management: Integration with device risk management (see ISO 14971) for both device‑related risks and procedures that deviate from standard of care.
- Post‑market clinical investigations: Principles to be applied as relevant to post‑market studies (Annex I considerations).
- SaMD considerations: Guidance on demonstrating analytical validity, scientific validity and clinical performance where relevant; allowances for indirect subject contact.
- Regulatory alignment: Annex ZA maps clauses to Annex XV of EU MDR to support presumption of conformity when cited in the Official Journal.
Applications
- Use this standard when planning and conducting pre‑market and relevant post‑market clinical investigations for medical devices, including:
- Design and review of clinical investigation plans and investigator’s brochures
- Protocol development, monitoring and sponsor oversight
- Preparation of clinical investigation reports to support regulatory submissions and conformity assessment
- Practical for device manufacturers, clinical research organizations (CROs), principal investigators, ethics committees, notified bodies and regulatory authorities seeking consistent GCP application.
Related standards
- EN ISO 14155 aligns with and references risk management standards such as ISO 14971 (application of risk management to medical devices).
- Users should check applicable national requirements and other referenced standards; where conflicts exist, the most stringent requirement applies.
Keywords: EN ISO 14155:2020/A11:2024, clinical investigation, good clinical practice, medical devices, SaMD, sponsor responsibilities, EU MDR, risk management, ISO 14971.
Frequently Asked Questions
EN ISO 14155:2020/A11:2024 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Clinical investigation of medical devices for human subjects - Good clinical practice". This standard covers: 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.
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.
EN ISO 14155:2020/A11:2024 is classified under the following ICS (International Classification for Standards) categories: 11.100.20 - Biological evaluation of medical devices. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14155:2020/A11:2024 has the following relationships with other standards: It is inter standard links to EN ISO 14155:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14155:2020/A11:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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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 c
...
EN ISO 14155:2020/A11:2024 표준은 인체를 대상으로 한 의료기기의 임상 조사에 대한 우수 임상 관행을 명확히 규정하고 있습니다. 이 표준의 범위는 의료기기의 임상 성능, 효과성 및 안전성을 평가하기 위한 임상 조사 디자인, 수행, 기록 및 보고에 관한 요구 사항을 포함하고 있습니다. 특히, 후시장 임상 조사의 경우 이 문서에서 제시된 원칙들을 적용하며, 해당 조사의 특성을 고려해야 함을 강조하고 있습니다. 표준의 주요 강점 중 하나는 인체 시험 대상자의 권리, 안전 및 복지를 보호하는 데 중점을 두고 있다는 점입니다. 이는 임상 조사에서 연구자의 윤리적 책임을 더욱 강화하며, 신뢰할 수 있는 임상 조사 결과를 보장하는 과학적 수행을 촉진합니다. 또한, 스폰서와 주요 조사자의 책임을 명확히 정의하여 모든 이해 관계자가 임상 조사에 대한 명확한 이해를 갖도록 돕습니다. EN ISO 14155:2020/A11:2024는 스폰서, 조사자, 윤리 위원회 및 규제 당국 등 의료기기의 적합성 평가에 관련된 다양한 주체들에게 유용한 참고 자료를 제공합니다. 또한, 소프트웨어가 의료기기인 경우에도 분석적 유효성 및 과학적 유효성과 관련된 요구 사항을 적용하도록 하고 있으며, 이는 신기술의 발전에 발맞추어 임상 조사에 있어서의 유연성을 제공합니다. 결론적으로, 이 표준은 임상 조사에 있어 가장 높은 수준의 윤리와 과학적 기준을 달성하는 데 필수적인 도구로 자리 잡고 있으며, 의료기기 분야에서의 안전성과 효과성을 담보하는 데 매우 중요한 역할을 합니다. 따라서 EN ISO 14155:2020/A11:2024은 모든 관련 기관 및 연구자들에게 필수적으로 참고해야 할 문서입니다.
La norme EN ISO 14155:2020/A11:2024 constitue une référence essentielle dans le domaine de la recherche clinique sur les dispositifs médicaux destinés à des sujets humains. Cette norme traite des bonnes pratiques cliniques en matière de conception, de réalisation, d'enregistrement et de rapport des investigations cliniques. Son champ d'application est clair et bien défini, s'appliquant tant aux essais cliniques préalables à la mise sur le marché qu'aux investigations cliniques post-commercialisation, nécessitant une conformité pertinente selon la nature de chaque investigation. Parmi les forces notables de cette norme, on retrouve son engagement clair pour la protection des droits, de la sécurité et du bien-être des sujets humains. Cela est crucial dans le contexte des essais cliniques, où la sécurité des participants doit toujours être la priorité. La norme établit également des exigences générales qui favorisent une conduite scientifique rigoureuse des investigations cliniques et garantissent la crédibilité des résultats. Cela renforce la confiance dans les produits médicaux qui en résultent, un aspect vital pour les acteurs dans le secteur. De plus, EN ISO 14155:2020/A11:2024 définit explicitement les responsabilités des sponsors et des chercheurs principaux, facilitant ainsi la clarté des rôles et des attentes dans le cadre des investigations cliniques. Cette clarté est essentielle pour les sponsors, les comités d'éthique, les autorités réglementaires et les autres organismes impliqués dans l’évaluation de conformité des dispositifs médicaux, favorisant une collaboration harmonieuse et efficace. Il est aussi important de noter que la norme reconnaît la nécessité d'intégrer d'autres normes et exigences nationales qui peuvent s'appliquer aux dispositifs d'investigation. Cette flexibilité permet d'assurer que les standards les plus rigoureux sont toujours respectés, tout en tenant compte des spécificités locales. En résumé, la norme EN ISO 14155:2020/A11:2024 est non seulement une ressource précieuse pour les professionnels engagés dans l'investigation clinique des dispositifs médicaux, mais elle joue aussi un rôle fondamental dans l'amélioration de la sécurité et de l'efficacité des soins de santé à travers le monde.
The EN ISO 14155:2020/A11:2024 standard, titled "Clinical investigation of medical devices for human subjects - Good clinical practice," serves as a comprehensive guide to ensure the integrity and ethical conduct of clinical investigations conducted on human subjects. Its scope effectively addresses the essential aspects of trial design, execution, recording, and reporting for assessing the performance, effectiveness, and safety of medical devices. One of the significant strengths of this standard is its emphasis on protecting the rights, safety, and well-being of human subjects involved in clinical investigations. It systematically outlines general requirements that stakeholders must adhere to, thereby promoting ethical research. This aspect not only enhances the credibility of clinical investigation results but also reinforces public confidence in the medical device industry. The standard further delineates the responsibilities of key players, such as sponsors and principal investigators, ensuring clarity and accountability throughout the investigative process. Additionally, it aids various parties-like sponsors, ethics committees, and regulatory authorities-by establishing a framework for conformity assessment of medical devices. This holistic approach enhances collaboration among stakeholders, thereby streamlining clinical investigation processes. Moreover, the standard recognizes the relevance of the principles outlined for post-market clinical investigations, adjusting for the unique nature of each study. This adaptability ensures that the foundational principles of good clinical practice are flexibly applied in varying contexts, especially in evolving fields such as Software as a Medical Device (SaMD). By accommodating the analytical and scientific validity requirements of SaMD, the standard maintains its contemporary relevance in the rapidly advancing landscape of medical technology. While the document does not directly apply to in vitro diagnostic medical devices, it thoughtfully acknowledges that specific sections may be relevant depending on national or regional requirements. This provision allows for a nuanced application of the standard in diverse regulatory environments. Overall, EN ISO 14155:2020/A11:2024 stands as a pivotal standard that enhances the rigor and reliability of clinical investigations of medical devices. Its robust guidelines not only safeguard human subjects but also contribute to the advancement of scientific knowledge and the overall efficacy of medical devices in clinical settings.
Die Norm EN ISO 14155:2020/A11:2024 ist ein bedeutendes Dokument, das die grundlegenden Prinzipien für die klinische Forschung von Medizinprodukten am Menschen regelt. Der Anwendungsbereich dieser Norm ist klar umrissen: Sie betrifft die guten klinischen Praktiken bezüglich der Planung, Durchführung, Dokumentation und Berichterstattung von klinischen Studien, die zur Bewertung der klinischen Leistung oder Effektivität und Sicherheit von Medizinprodukten durchgeführt werden. Ein zentraler Vorteil dieser Norm ist der Fokus auf den Schutz der Rechte, Sicherheit und des Wohlbefindens der Probanden. Sie legt allgemeine Anforderungen fest, die sicherstellen, dass die wissenschaftliche Durchführung der klinischen Forschung und die Glaubwürdigkeit der Ergebnisse gewährleistet sind. Dies ist besonders wichtig, um das Vertrauen in die Resultate von klinischen Untersuchungen und die Zulassung von Medizinprodukten zu stärken. Ein weiteres starkes Merkmal dieser Norm ist die klare Definition der Verantwortlichkeiten sowohl des Sponsors als auch des Hauptuntersuchers. Diese Transparenz hilft, Missverständnisse zu vermeiden und die Qualität der klinischen Studien zu verbessern. Zudem bietet die Norm Unterstützung für Sponsoren, Prüfer, Ethikkommissionen, Regulierungsbehörden und andere beteiligte Stellen, die in die Konformitätsbewertung von Medizinprodukten involviert sind. Die Norm berücksichtigt auch die Notwendigkeit, dass bei post-marktlichen klinischen Studien die darin festgelegten Prinzipien beachtet werden. Dies zeigt die Relevanz und Flexibilität der Norm in unterschiedlichen Phasen der Produktentwicklung und -überwachung. Insbesondere bezüglich Software als Medizinprodukt (SaMD) werden spezifische Anforderungen an die analytische und wissenschaftliche Validität sowie die klinische Leistung hervorgehoben, die für moderne gesundheitstechnologische Entwicklungen von großer Bedeutung sind. Es ist zu beachten, dass die Norm nicht auf in-vitro-diagnostische Medizinprodukte anwendbar ist, was jedoch unter bestimmten Umständen diskutiert werden kann, abhängig von spezifischen Anforderungen. Diese Flexibilität macht die Norm anpassungsfähig an verschiedene nationale und regionale Gegebenheiten. Insgesamt ist die EN ISO 14155:2020/A11:2024 eine essenzielle Norm, die nicht nur die Integrität klinischer Studien fördert, sondern auch einen wichtigen Beitrag zur Sicherheit und zum Schutz der Probanden in der medizinischen Forschung leistet. Die umfassende Regelung guter klinischer Praktiken macht sie zu einem unverzichtbaren Leitfaden für alle Akteure im Bereich der Klinischen Forschung von Medizinprodukten.
SIST EN ISO 14155:2020/A11:2024は、医療機器の臨床調査における良好な臨床実践に関する国際規格として、極めて重要な役割を果たしています。この標準は、ヒト被験者を対象とした臨床調査の設計、実施、記録及び報告に関する要件を明確に定義しており、医療機器の臨床性能、有効性、安全性を評価するために必要なガイドラインを提供します。 この文書の範囲は、臨床調査の倫理的側面を重視し、被験者の権利、安全、福祉を保護することに重点を置いています。さらに、臨床調査の科学的な実施及び結果の信頼性を確保するための一般的な要件が詳細に規定されており、スポンサーや主な研究者の責任も明瞭にしています。この点において、SIST EN ISO 14155は、医療機器の適合性評価に関与する倫理委員会や規制当局に対しても具体的なサポートを提供しています。 また、本標準は、医療機器の市場後調査に対しても適用され、その際の臨床調査の性質に応じて原則を遵守することが求められています。この適用範囲の柔軟性は、様々な医療機器に対応可能な強みとなっています。さらに、ソフトウェアとしての医療機器（SaMD）についても、分析的妥当性や科学的妥当性、臨床性能の要求が関連する限り適用される旨が明記されており、最新の技術革新にも対応しています。 最後に、この文書は体外診断用医療機器には適用されないものの、特定の状況下では適用される可能性があることを強調しており、医療機器に関連するさまざまな国際的及び国内的要件について考慮する必要性を示しています。どのような医療機器でも、最も厳格な要件が優先されるべきであり、そのための明確な指針を提供する本標準は、医療機器の臨床調査における基盤となっています。
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