Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice. The new ISO 14155:2020 provides an alignment with Medical Device European Regulation and with other international regulation. This posts wants to have an overview of the main changes introduced with the new version. If you want to have an overview of QMS requirements you can click here: Quality Management for Organizational Excellence: Introduction to Total Quality (2-downloads)
The new ISO 14155:2020 – Clinical Investigation for Medical Devices – supports medical device manufacturers in the implementation of GCP and in general in the organization and conduction of clinical studies.
We have been addressing several aspects related to the clinical process within QualiyMedDev website, such as for example, the requirements associated to Clinical Evaluation Plan, the Summary of Safety and Clinical Performance and the clinical investigation procedure to be included within the quality management system.
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Most Important Changes
Firstly, the biggest changes in this third version of ISO 14155:2020 is the reinforcement of the concept of risk management through all the phases of the clinical investigation process. This comes as requirements from the ISO 14971:2019 (apply risk management through the whole life cycle of the product).
Moreover, other changes have been implemented to facilitate the compliance to other regulatory standards such as GCP/ICH. Furthermore big emphasis has been provided on the concept of clinical evidences, as defined according to EU MDR 2017/745.
Details of the Changes
Going more in details, specific changes addressed on the new version of ISO 14155:2020 are the following:
- Inclusion of a summary of GCP principles;
- Added a guidance on clinical quality management, clinical investigation audits, statistical considerations;
- Reference of guidance for ethics committees;
- Inclusion of Risk-based monitoring requirements;
- Reference to registration of clinical investigations in publicly accessible databases,
- Clarifications on how ISO 14155 requirements apply to each stage of clinical development;
- Inclusion of annexes relating ISO 14155 to the European Medical Devices Regulation, and to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).
In conclusion, this new version of the ISO 14155 provides an alignment with the EU MDR regulation. Moreover, it facilitates compliance with other International regulation for clinical investigation of medical devices.
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