Understand The Iso 14155 Standard And Its Requirements

By Author: John
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The ISO 14155 international standard defines good clinical practices for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to measure the safety and performance of medical devices for regulatory purposes. Though, it does not apply to in vitro diagnostic medical devices. ISO 14155 standard was established by ISO technical committee ISO/TC 194. The ISO 14155-1 first edition was published on 15 February 2003, also the second edition was published in February 2011 and the third edition was released in July 2020. The ISO 14155 standard explains the high-tech approach for the clinical development strategy for medical devices with the purpose to gather, record, and analysed relevant data on the quality, performance, and safety of a device during its complete life cycle covering pre-and post-market stages.

The principles described in ISO 14155 standard also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations. Here are some changes in ISO 14155 ...
... standard are as follow:

•Locus on the registration of the clinical investigation in a publicly accessible database
•Management of risk-based monitoring and attention when writing the monitoring plan
•Guidance on statistical considerations, in line with growing requirements by notified bodies
•Guidance for Ethics Teams
•Management of clinical investigation audits, in line with clinical quality management
•Reinforcement of risk management given to ISO 14971 throughout the entire process of a clinical investigation
•Requirements for explicit medical expertise in the planning of clinical investigations.

So, ISO 14155 provides the general specifications and requirements for clinical investigations of medical devices. The newest version of the standard ISO 14155:2020 is intended to serve as a guide for clinical research professionals during the design, conduct, recording, and reporting of clinical trials associated with the safety and effectiveness of medical devices.

The latest version of ISO 14155:2020 ensures that the standard maintains harmonization with other international standards as well as global acceptance. ISO 14155 has an affiliation with ISO 14971 in that the application of risk management principles must be used across all stages of the clinical investigation. “Clinical risk management” is now added to the list of responsibilities of the sponsor. ISO 14155 documents should contain all the requirements in the proper written format as per implemented system. it’s also important to note that clinical investigation planning requires the inclusion of personnel with relevant medical expertise.

The ISO 14155 standard specifies general requirements to:

•Defend the rights, safety, and well-being of human subjects
•Certify scientific conduct of the clinical investigation and credibility of the clinical investigation results;
•Describe the responsibilities of the sponsor and principal investigator
•Assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.

Also implementing a clinical investigation management system of medical devices as per ISO 14155:2020 standard in the organizations can achieve the benefits with continuous improvements, it helps to improve clinical practices and performances, also an effectively implemented system ensures scientific conduct of the clinical investigation and credibility of the clinical investigation results. ISO 14155-based system assists sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices and well-defined responsibilities of the sponsor and principal investigator.