PERSONS CONCERNED: Regulatory Affaires and Quality Managers
Contexte Réglementaire
This document relates to the good clinical practices (GCP) applicable to the design, management, registration and reports concerning pre-market clinical investigations, carried out on human subjects with a view to evaluating the clinical performance or efficacy and safety of medical devices.
The principles defined in this document also apply to post-market clinical investigations, principles that should be followed, as long as they are relevant, taking into account the nature of the investigation and the requirements imposed by national regulations (see Appendix I).
This document sets out the general requirements for:
- Protecting the rights, safety and well-being of human subjects,
- Ensuring the scientific conduct of the clinical investigation and the credibility of the investigation results,
- Defining the responsibilities of the developer and main investigator, and
- Helping developers, investigators, ethics committees, regulatory authorities and other bodies involved in evaluating the compliance of medical devices.
NOTE 1: This standard can be used for regulatory purposes.
NOTE 2: Users of this international standard must assess whether other standards and / or requirements may also apply to the device(s) under investigation.
NOTE 3: For software as a medical device (SaMD), the justifications for exemption from this standard can take into account the particularity of the indirect contact between the subjects and the SaMD. However, the analytical validity (SaMD output is correct for a given input), if applicable, scientific validity (SaMD output is associated with the expected clinical / psychological state), and clinical performance (SaMD output generates a clinically significant association for the target use) of the SaMD must be demonstrated.
This document does not apply to in-vitro diagnostic medical devices.
Analysis
This third edition cancels and replaces the second edition (ISO 14155:2011), which was subject to technical revision.
The main modifications in relation to the previous edition are the following:
ADDITION OF A SECTION SUMMARISING THE PRINCIPLES OF GOOD CLINICAL PRACTICES (gcp)
(see Article 4)
4 Summary of the principles of Good Clinical Practices (GCP)
Reference to the registration of the clinical investigation on a public database (see 5.4).
In accordance with national regulations or the Helsinki Declaration, a description of the clinical investigation must be registered in the public database, prior to recruitment of the first subject.
When national regulations require, the content must be updated throughout the duration of the clinical investigation and the results must be entered at the end of the investigation.
ADDITION OF RECOMMENDATIONS CONCERNING CLINICAL QUALITY MANAGEMENT
(see 9.1)
The quality management principles must apply to the clinical investigation processes, in order to guarantee that the investigation is deigned, carried out and monitored, and that the data generated, recorded in a document, is registered, evaluated and communicated in accordance with this international standard, the clinical investigation plan, any other subsequent amendment as well as any other applicable regulatory standards and requirements. The developer must:
a) implement and update the written clinical quality procedures,
b) keep record to guarantee the compliance of all parties involved in the clinical investigation,
c) ensure that the audit requirements indicated in 7.11 are met, if applicable, and
d) explain and record, in a document, the significant exceptions to the requirements of this international standard (also see Appendix I for examples of exemptions).
The clinical quality procedures can be included in the sections applicable to the developer’s global quality assurance systems.
INTRODUCTION OF THE risk-based SURVEILLANCE STRATEGY
(see 6.7)
The developer must determine the scope and nature of the surveillance appropriate to the clinical investigation and the generation of timely reports, including the source data verification strategy in relation to the centralised control of the data (evaluation without visiting the investigation site) and the protection of subjects, based on the risk assessment carried out by the developer (see 6.2). The objective, design, complexity, size, critical data points and judgement criteria of the clinical investigation as well as the level of discrepancy in relation to normal clinical practice must also be paid additional attention.
ADDITION OF RECOMMENDATIONS AS PART OF THE STATISTICAL CONSIDERATIONS
(see Appendix A)
ADDITION OF RECOMMENDATIONS FOR ETHICS COMMITTEES
(see Appendix G)
CONSOLIDATION OF RISK MANAGEMENT THROUGHOUT THE CLINICAL INVESTIGATION PROCESS
(from the planning through to the consideration of the results), including Appendix H
CLARIFICATION OF THE APPLICABILITY OF REQUIREMENTS OF THIS STANDARD TO THE VARIOUS STAGES OF CLINICAL DEVELOPMENT
(see Appendix I)
ADDITION OF RECOMMENDATIONS RELATING TO CLINICAL INVESTIGATION AUDITS
(see Appendix J)