Introduction to ISO 14155
ISO 14155 is an international standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices. The standard is intended to ensure that clinical investigations are conducted in a safe, ethical, and scientifically sound manner and that the resulting data is reliable and relevant. Compliance with ISO 14155 is mandatory for medical device manufacturers who wish to obtain regulatory approval for their products in Europe.
ISO 14155 Test Method
The ISO 14155 standard provides guidance for clinical investigations of medical devices, including the following key procedures:
| Clinical Investigation Plan (CIP) | The CIP describes the objectives, design, methods, and statistical considerations of the clinical investigation. |
| Investigational Device | The Investigational Device is the medical device being tested in the clinical investigation. |
| Investigator’s Brochure (IB) | The IB contains information about the Investigational Device, including its composition, design, manufacturing process, and other relevant information. |
| Informed Consent | Informed consent is obtained from all participants in the clinical investigation. Participants must be fully informed of the risks and benefits associated with the investigation and must provide their voluntary consent to participate. |
| Monitoring | Monitoring of the clinical investigation is carried out to ensure that the investigation is conducted in accordance with the CIP and that the data collected is accurate and reliable. |
| Adverse Events Reporting | Adverse events that occur during the clinical investigation must be reported to the relevant authorities in a timely manner. |
| Record Keeping | Records must be kept of all aspects of the clinical investigation, including the CIP, the IB, informed consent documents, monitoring reports, and adverse event reports. |
ISO 14155 Specimens
ISO 14155 applies to all medical devices intended for human use, including implantable devices, diagnostic devices, and therapeutic devices. The standard is designed to ensure that clinical investigations are conducted in a safe, ethical, and scientifically sound manner and that the resulting data is reliable and relevant. Compliance with ISO 14155 is mandatory for medical device manufacturers who wish to obtain regulatory approval for their products in Europe.
ISO 14155 Results
The ISO 14155 standard is intended to help medical device manufacturers achieve the following outcomes
Safety and effectiveness of medical devices:
Clinical investigations carried out in accordance with ISO 14155 are designed to ensure that medical devices are safe and effective for their intended use.
Compliance with regulatory requirements:
Medical device manufacturers who wish to obtain regulatory approval for their products in Europe must comply with ISO 14155.
Reliable and relevant data:
Clinical investigations carried out in accordance with ISO 14155 are designed to ensure that the resulting data is reliable and relevant.
Tests related to ISO 14155
ISO 14155 is similar to other medical device standards, such as ISO 13485 and ISO 14971, in that it ensures that medical devices are safe and effective for their intended use. ISO 14155 is also aligned with other clinical investigation standards, such as the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP).
