[ Certification Introduction ]

ISO 14155 is an international standard for Clinical research of medical devices for human subjects – Good Clinical Practice (GCP) and, is a certification about clinical trial management standards in relation to the design, perform, recording, and reporting of medical devices clinical trials.

Currently, most medical devices are undergoing clinical research to ensure product stability and performance. The data researched after this clinical research are used to assess the suitability of that medical device. Therefore, results obtained through correct clinical research are essential, and incorrectly designed clinical research plans can make it difficult to ensure the stability and performance of medical device products and companies for the purpose of clinical research.

ISO 14155 provides detailed guidance on the principles and procedures, information to be collected process of clinical trials to prevent this situation in advance, protect subjects, and collect accurate clinical data throughout the clinical trials' planning and perform and verification.

However, IVD, an in vitro diagnostic medical device, is excluded from the application target of the ISO 14155 standard, and the IVD's clinical trial management criteria exist separately by the ISO 20916 standard.

[ ISO 14155:2020 Certification Target ]

Recently, the application of medical device CE MDR in Europe and the increase in medical device and New drug development have attracted much attention about ISO 14155, and ISO 14155 certification targets may be all institution that has a clinical trial process.

• Clinical trial consignment agency (CRO)
• Institution for conducting clinical trials.
• Clinical Data Monitoring Agency

[ ISO 14155:2020 Certification Objective ]

• •  Protect trial subjects: Protects the quality of life as well as the rights and safety of clinical trial subjects.
• •  Ensure reliability through scientific clinical trial processes: The reliability of clinical trial results can also be guaranteed by ensuring the scientific conduct of clinical trials.
• •  Regulation of Responsibility scope: It would like to regulate the scope of responsibility of the client and the clinical trial director.
• •  Support for conformity evaluation: Support clients, Testers, ethics committees, regulation institutions, etc. in relation to the conformity evaluation of medical devices.

[ ISO 14155:2020 Requirements ]

ISO 14155:2020 is a standard that deals with not only the clinical trial management standards (GCP) but also, the concept of research audit by clients, researchers, and sites in relation to the quality control process of clinical trials. Therefore, it is possible to approach step by step for things that need to be considered ethically when clinical research and derive reliable clinical data.

This standard also addresses the requirements for appropriate methodologies to protect the rights and safety of test participants and ensure scientific reliability of clinical data, while defining the responsibility of sponsors and researcher and explaining the roles of ethics committees, regulators, safety committees, and related parties.

Medical device production companies are must meet the requirements of the ISO 14155 standard vitally when conducting clinical trials to demonstrate the stability of the product and its effectiveness according to the purpose of use.

• Scope
• Normative reference
• Terms and definitions
• Summary of good clinical practice (GCP) principles
• Ethical considerations
• Clinical research planning
• Clinical research conduct
• Suspension, termination, and close-out of the clinical research
• Responsibilities of the sponsor
• Responsibilities of the principal researcher

[ The importance of ISO 14155:2020 ]

• 1. Currently, not only the EU but also the United States, Canada, Brazil, Australia, Japan, China, and Russia recognizes clinical trials and clinical data for medical devices based on ISO 14155 standards, and the scope to which certification can be applied, so their importance and efficiency are gradually increasing.
• 2. In order to export medical devices to the European Union (EU) market from May 2024, clinical trial perform is essential for medical devices with high risk ratings under MDR regulations, and clinical data and research results conducted under ISO 14155 standard is possible to accepted validly.

[ The effect of ISO 14155:2020 ]

• •  If clinical trials are conducted based on ISO 14155 standards, the subject's rights and safety are guaranteed, and more objective and reliable scientific clinical data can be collected.
• •  All risk factors related to the medical device can be identified.
• •  For CE certification and FDA approval for existing overseas exports, clinical trials conducted overseas by proceeding in Korea, the stability and efficacy of medical device development are improved to the global level.
• •  Domestic medical device companies can quickly conduct clinical trials tailored to the new regulations at a more convenient and reasonable cost in Korea without going through overseas medical institutions to ensure the performance of medical devices and the stability of the subjects
• •  ISO 14155 certification contributes to the entry of domestic medical devices into the global market, as the US FDA accredits the results of clinical researches conducted outside the US based on ISO 14155.
• •  It can handle global-level clinical trial data and document preparation work even in Korea.