SIST EN ISO 14155:2020/A11:2025
(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
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
SIST EN ISO 14155:2020/A11:2025 is a amendment published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN ISO 14155:2020/A11:2025 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general; 11.100.20 - Biological evaluation of medical devices. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 14155:2020/A11:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 14155:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 14155:2020/A11:2025 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
...
SIST EN ISO 14155:2020/A11:2025は、医療機器の臨床調査における優れた臨床実践を確保するための重要な標準文書です。この標準は、ヒト被験者に対して行われる臨床調査の設計、実施、記録、報告に関する良好な臨床実践を扱っており、その範囲は非常に広いです。特に、医療機器の臨床性能や有効性、安全性を評価するための方法論が詳細に記載されています。 この標準の強みは、参加する被験者の権利、安全性、福利を保護するための一般的な要求事項を明確に定義している点です。これにより、臨床調査が科学的に実施され、結果の信頼性が確保されることが期待されます。また、スポンサーや主研究者の責任を明示することで、関係者間の役割分担が明確になり、調査の円滑な進行が可能になります。 さらに、SIST EN ISO 14155:2020/A11:2025は、倫理委員会や規制当局など、医療機器の適合性評価に関与する他の機関を支援するためのガイドラインも提供しています。これは重要であり、医療機器が市場に出る前後の臨床調査において関連する原則に従うことが推奨されます。 この標準は、ソフトウェアを医療機器として扱う場合（Software as a Medical Device, SaMD）にも適用可能ですが、その際には特有の要件を考慮する必要があります。特に、SaMDの分析的妥当性、科学的妥当性、臨床性能についての基準が求められます。これにより、サブスタンダードとしての治療効果のある出力を確保するための基盤が形成されます。 ただし、体外診断医療機器には適用されないことに注意が必要ですが、デバイスや地域の要件に応じて、特定のセクションが適用される場合もあり、この点での柔軟性も持たれています。 総じて、SIST EN ISO 14155:2020/A11:2025は、医療機器の臨床調査における良好な臨床実践を確立するための基本的かつ重要なドキュメントであり、医療技術の進歩に寄与する上で関連性が高いと言えます。この標準を通じて、医療機関と研究者や規制機関との連携が強化され、より安全で効果的な医療機器の開発が期待されます。
La norme SIST EN ISO 14155:2020/A11:2025 représente un cadre essentiel pour la conduite d'investigations cliniques sur des dispositifs médicaux destinés à des sujets humains. Son ambition principale est de garantir des pratiques cliniques de qualité, en fournissant des directives claires pour la conception, la réalisation, l'enregistrement et le reporting des investigations cliniques. Le champ d'application de la norme est pertinent et bien défini, car il englobe également les investigations cliniques post-commercialisation. Les principes de cette norme sont conçus pour protéger les droits, la sécurité et le bien-être des sujets humains, un aspect fondamental pour maintenir la confiance dans les essais cliniques. En insistant sur la rigueur scientifique des investigations cliniques, la norme assure également la crédibilité des résultats, un facteur crucial pour l'acceptation des dispositifs médicaux sur le marché. Parmi ses forces, la norme précise les responsabilités tant du promoteur que de l'investigateur principal, ce qui contribue à clarifier les rôles dans le cadre des essais cliniques. Cette clarté est bénéfique pour tous les acteurs impliqués, y compris les comités d'éthique et les autorités réglementaires, facilitant ainsi l'évaluation de la conformité des dispositifs médicaux. Il est également important de noter que cette norme prend en considération les autres standards nationaux et exigences qui pourraient être applicables aux dispositifs d'investigation, soulignant la nécessité de respecter les exigences les plus strictes. La norme aborde aussi les spécificités des logiciels en tant que dispositifs médicaux (SaMD), en posant des exigences pour démontrer la validité clinique et scientifique, ce qui est essentiel dans un contexte technologique en constante évolution. En résumé, la norme SIST EN ISO 14155:2020/A11:2025 se distingue par sa portée exhaustive et ses lignes directrices rigoureuses, faisant d'elle un outil indispensable pour les investigations cliniques de dispositifs médicaux, garantissant ainsi leur sécurité et leur efficacité pour les sujets humains.
Die Norm SIST EN ISO 14155:2020/A11:2025 bietet einen umfassenden Rahmen für die klinische Untersuchung von medizinischen Geräten an menschlichen Probanden, wobei der Schwerpunkt auf der Einhaltung guter klinischer Praktiken (GCP) liegt. Diese Norm ist von entscheidender Bedeutung für die Gestaltung, Durchführung, Dokumentation und Berichterstattung klinischer Untersuchungen, die zur Bewertung der klinischen Leistungsfähigkeit und Sicherheit von Medizinprodukten durchgeführt werden. Ein herausragendes Merkmal dieser Norm ist ihr klar definierter Anwendungsbereich, der nicht nur die Rechte und das Wohlbefinden der Versuchspersonen schützt, sondern auch die wissenschaftliche Integrität der klinischen Untersuchung sichert. Die in der Norm festgelegten allgemeinen Anforderungen sind darauf ausgelegt, die Verantwortlichkeiten von Sponsoren und Hauptforschern zu definieren und bieten so eine wertvolle Orientierung für alle Beteiligten, einschließlich Ethikkommissionen und Zulassungsbehörden. Die Norm berücksichtigt ebenfalls post-marktliche klinische Untersuchungen und betont, dass die Prinzipien der guten klinischen Praxis auch in diesen Fällen anwendbar sind, wobei die spezifische Natur der untersuchten klinischen Ermittlungen berücksichtigt wird. Dies zeigt die Relevanz der Norm für den gesamten Lebenszyklus von medizinischen Geräten, von der Forschungs- und Entwicklungsphase bis zur Markteinführung und darüber hinaus. Darüber hinaus wird in der Norm auf die Notwendigkeit hingewiesen, auch andere anwendbare Standards oder nationale Anforderungen zu berücksichtigen, was ihr eine zusätzliche Flexibilität und Anpassungsfähigkeit verleiht. Insbesondere im Kontext von Software als Medizinprodukt (SaMD) legt die Norm Richtlinien fest, die sicherstellen, dass analytische und wissenschaftliche Validität sowie klinische Leistungsfähigkeit konsistent angewendet werden. Zusammenfassend lässt sich sagen, dass die SIST EN ISO 14155:2020/A11:2025 eine grundlegende Norm für alle Beteiligten im Bereich der klinischen Forschung zu medizinischen Geräten darstellt. Ihre Stärken liegen in der umfassenden Abdeckung aller relevanten Aspekte der klinischen Untersuchung und in der Klarheit der festgelegten Anforderungen, wodurch sie als unverzichtbares Werkzeug zur Gewährleistung von Sicherheit und Effizienz im Bereich der klinischen Prüfungen dient.
SIST EN ISO 14155:2020/A11:2025 표준은 인체를 대상으로 한 의료기기의 임상 조사에 대한 좋은 임상 관행을 다루고 있습니다. 이 문서는 임상 성능, 효과성 및 안전성을 평가하기 위해 수행되는 임상 조사의 설계, 수행, 기록 및 보고에 관한 전반적인 요구 사항을 제시합니다. 표준의 주요 초점은 인간 피험자의 권리, 안전 및 복지를 보호하고, 임상 조사 결과의 과학적 수행과 신뢰성을 보장하며, 스폰서와 주요 연구자의 책임을 정의하는 데 있습니다. 본 문서의 강점 중 하나는 다양한 이해당사자, 즉 스폰서, 연구자, 윤리 위원회, 규제 기관 및 의료기기 적합성 평가에 관련된 기타 기관들이 이 표준을 활용하여 서로 협력할 수 있도록 돕는 점입니다. 이로 인해 임상 조사 결과가 보다 일관되고 신뢰할 수 있는 방식으로 도출될 수 있습니다. 또한, 문서 내의 지침은 사후 시장 임상 조사에도 적용 가능한 원칙들을 포함하고 있어, 다양한 상황에서 적절하게 적용될 수 있다는 장점이 있습니다. 사전 예외 조항 덕분에 소프트웨어를 의료기기로 사용하는 경우에도 이 표준의 요구 사항을 적용할 수 있으며, 이에 따라 SaMD의 분석적 유효성과 임상 성능을 보장할 수 있습니다. 이는 기술적으로도 매우 중요하며, 변화하는 의료기기 환경에 적절히 대응할 수 있게 해 줍니다. 또한, 이 문서는 인 vitro 진단 의료기기에는 적용되지 않지만, 특정 경우에는 사용자가 문서의 특정 섹션이나 요구 사항이 적용될 수 있는지를 고려하도록 하고 있는 점도 중요합니다. 따라서 각 국의 요구 사항이나 장비의 특성에 따라 이 표준의 유의미한 활용성을 보장할 수 있습니다. 결론적으로, SIST EN ISO 14155:2020/A11:2025 표준은 의료기기 임상 조사의 품질을 보장하고, 모든 관련 당사자들이 안전하고 효과적으로 협력할 수 있도록 돕는 강력한 근거를 제공합니다. 이 표준의 적용은 의료기기 개발과 평가 과정의 신뢰성을 크게 향상시킬 것으로 기대됩니다.
The standard SIST EN ISO 14155:2020/A11:2025 provides comprehensive guidance on good clinical practice (GCP) for the clinical investigation of medical devices involving human subjects. The scope of this standard is particularly relevant as it outlines essential principles for document preparation, execution, reporting, and accountability. This includes safeguarding the rights, safety, and welfare of participants, which is crucial in conducting ethical medical research. One of the standout strengths of this standard is its balanced approach to ensuring the scientific rigor of clinical investigations, while maintaining high ethical standards. By defining the responsibilities of sponsors and principal investigators, the document establishes clear roles that help enhance accountability and transparency within clinical trials. This is essential for building trust among stakeholders, including ethics committees and regulatory authorities. The document is also notable for its pertinent applicability to post-market clinical investigations. It offers flexibility by allowing relevant principles to be adapted based on the nature of the investigation, which is critical in a rapidly evolving landscape of medical technology. This adaptability ensures that varying types of medical devices, including Software as a Medical Device (SaMD), can be assessed effectively while maintaining compliance with GCP. Furthermore, the standard aids stakeholders in adhering to regulatory requirements by emphasizing the need for a robust scientific foundation for clinical results. This aspect of the standard is critical for the credibility of clinical investigations, enabling sponsors and investigators to produce findings that can withstand scrutiny in both regulatory submissions and market evaluations. Though the document explicitly excludes in vitro diagnostic medical devices, it encourages users to contemplate whether certain sections may still apply, demonstrating a nuanced understanding of diverse clinical contexts. This aspect reinforces the standard’s relevance in diverse clinical scenarios while guiding users to consider other applicable regulations. Overall, SIST EN ISO 14155:2020/A11:2025 serves as a pivotal standard in the realm of clinical investigations for medical devices, offering comprehensible guidelines to ensure ethical practices and scientific integrity. Its detailed provisions and clear delineation of responsibilities play a vital role in advancing the field of medical device research, thus benefiting various stakeholders engaged in clinical investigations.
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