En Iso 14155

[Christain Cobb]

ISO14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 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.

ISO 14155:2011 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 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.

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This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices.

The standard ISO 14155:2011 is an assessable standard and hence is certifiable. The standard regards good clinical practices and protocols for the clinical investigations and plans of medical devices. The assessment is carried out following defined protocols in this international standard.

Clinical investigations play an important role in your journey of bringing a medical device to market. While they are often perceived as difficult and complex, having a good grasp of the relevant standards can help make the process less confusing.

Which parts of ISO 14155 will apply to your clinical study?

What is Good Clinical Practice (GCP)?

What are the key responsibilities of the sponsor and principal investigator during a clinical investigation?

How to plan a clinical investigation according to ISO 14155:2020

How to conduct a clinical investigation in accordance with ISO 14155:2020

Managing risks during a clinical investigation

Electronic data capture and compliance with ISO 14155:2020

Final thoughts: Greenlight Guru Clinical is pre-validated for MedTech data collection requirements

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

The ISO 14155:2020 and ISO 14155:2011 differ significantly. The 2020 version puts more emphasis on applying risk management principles throughout the entire medical device clinical investigation process.

Annex H of ISO 14155 (Application of ISO 14971 to clinical investigations) explicitly lays out the connection between ISO 14971 and the clinical investigation process. It includes a helpful graphic for applying ISO 14971 to the management of potential safety concerns during a medical device clinical investigation.

The standard writers have attempted to clear up some of this confusion in ISO 14155:2020 with the addition of Annex I, which clarifies the different types of clinical investigations based on regulatory status, clinical development stage, study design, and burden to subject.

The important thing to remember is that if you believe you are exempt from applying any part of this standard to your medical device clinical investigation, you must justify that decision in your clinical investigation plan (CIP).

ISO 14155 provides a summary of GCP principles in Section 4 of the standard. These principles are essential for conducting research with human subjects. They form the basis of any good clinical study.

Now, that basic description of CRFs is deceptively simple. Case report forms are one of the chosen methods of collecting clinical data during a study. Using paper or general-purpose software for your CRFs puts you at risk for missing data or data entry mistakes. These can slow down your study significantly.

At Greenlight Guru, our modern eCRF is built for the unique needs of the MedTech industry. When you use Greenlight Guru Clinical, you can get started very quickly. Ensure peace of mind with our pre-validated software, regulatory templates, and user-friendly study builder.

Fortunately, Greenlight Guru Clinical offers an adverse event module for EU MDR and ISO 14155-compliant reporting. The customizable module is fully integrated into our eCRF and provides automatic notifications to users and sponsors and an AE specific data export.

The emphasis here on using ISO 14971 and applying risk management principles throughout the clinical investigation is part of a larger, industry-wide move toward integrating risk management into every part of the medical device lifecycle.

Taking this kind of holistic approach to risk means you may even want to document risk management for clinical investigations within your quality management system. Risk management activities during a Post-Market Clinical Follow-Up investigation may have important implications for the device. These should be documented and tracked in the Quality Management System.

At Greenlight Guru, we understand that risk is a fundamental part of bringing a medical device to market. We built our Risk Management workspace to be traceable and compliant with ISO 14971:2019 and ISO 13485:2016. This ensures our workspace meets the risk-based requirements of both standards.

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The ISO 14155 standards were created to clarify the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. ISO 14155 is in its second edition: ISO 14155:2011. While ISO 14155 is not law in the United States, it plays a role similar to ICH Good Clinical Practices Guidelines (E6) and has been officially recognized as a standard by the FDA since 16 March 2012.

The 21 CFR 812.100 requires that the sponsor ensures that the investigation is conducted according to the FDA regulations, as well as the investigator agreement, the investigational plan, and written requirements of the Institutional Review Board (IRB) under which the investigation is being conducted.

If any of these regulatory documents specify that the study should be conducted according to ISO 14155 standard, the investigator must also comply with these guidelines. Even if ISO 14155 is not required, such in the case of post market studies, it is still good practice to conduct medical device trials to this higher standard because doing so affords greater participant protection and data integrity. In addition, some national regulations require compliance with ISO 14155, regardless the regulatory status of the product so it is wise to consult the specific regulatory body.

FDA regulations and ISO 14155 standards include many overlaps, but also some unique aspects. To comply with both, it is important to understand these differences. The following tables and discussions compare FDA regulations and ISO 14155 in the five areas where FDA investigators most often find noncompliance with FDA regulations. Please download the complete white paper here.

Summary: ISO standards require conducting the investigation in accordance with the clinical investigation plan, whereas FDA regulations also require the investigation to be conducted according to the signed investigator agreement, FDA regulations, and conditions of the IRB.

Summary: ISO requires the principal investigator or designee to sign and date printed as well as electronic CRFs. Additionally, ISO specifies that printed electronic source documents must be signed and dated with a statement indicating they are a true reproduction of the original. ISO requires the use of a delegationlog. FDA requires record retention for two years and 10 working days to notify FDA of any records transfer.

Summary: FDA regulations require recording the names of all persons who received, used or disposed of each device, as well as the when each device was used. ISO standards require the investigator to keep records documenting expiry date.

Whether conducting a US-based study with additional sites OUS or conducting an entire study outside the US, sponsors must stay well-informed about the multiple national and international requirements set to ensure a well-controlled trial that will withstand the scrutiny of worldwide regulatory agencies. While conducting a trial under the umbrella of both 21 CFR and ISO 14155:2011 (ISO 14155) will position the sponsor well globally at trial end, implementing these dual standards can also create confusion during study conduct.

The FDA seeks to protect public health and human subject well-being through cautious oversight of all US clinical device trials, and similarly the ISO 14155 was created to provide a worldwide guidance to the design, conduct, recording, and reporting of clinical investigations carried out in human subjects that assess the safety or performance of medical devices for regulatory purposes.

Conducting an investigation according to both principles should result in the highest integrity device trial that affords the most stringent level of protection for human research subjects. While this may be challenging, it can be accomplished with proper preparation. Ensuring trials comply with both sets of standards allows companies that conduct international trials to feel confident that the resulting data is acceptable not only in the US, but also to worldwide regulatory agencies. Please take time to consult our website (www.akrnconsulting.com) and let us know if you need our help to plan your clinical trials.

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