Clinical Investigation / Trials for Medical Devices
A clinical investigation is the outcome of extensive research and development, aimed at evaluating the safety and effectiveness of a medical treatment intended for human use. Within the context of the ISO 14155 standard, the terms “clinical investigation,” “clinical trial,” and “clinical study” are often used interchangeably, referring to the same process.
This standard defines a clinical investigation as a systematic study involving human subjects to assess the performance, safety, or effectiveness of a medical device. By adhering to strict protocols, medical device clinical trials explore critical aspects of medical devices, ensuring that they meet required safety standards. These clinical trials in medical devices play a vital role in advancing medical science, improving patient care, and facilitating the development of innovative healthcare solutions. Following comprehensive guidelines ensures that the results of the trials are credible, allowing regulatory authorities to make informed decisions about device approval. Ultimately, clinical investigations contribute significantly to the ongoing enhancement of medical technologies and treatments.
Key Documents required for Clinical Investigation
A clinical investigation for a medical device requires meticulous documentation to ensure compliance and successful approval. Key documents include the Investigator’s Brochure, which provides detailed information about the medical device and its intended use, and the Clinical Investigation Plan (CIP), outlining the study objectives, methodology, and protocols. Additionally, an Ethics Committee approval certificate and informed consent forms are mandatory to protect participant rights. For medical device clinical trials, detailed records of preclinical data, Good Laboratory Practice (GLP) certifications, and manufacturing details must also be included. Proper documentation ensures that clinical trials in medical devices meet regulatory standards and deliver reliable results.
Purposes of a Clinical Investigation in Medical Devices
Clinical investigations play a crucial role in advancing healthcare by ensuring the safety and efficacy of medical devices and treatments. One primary aim of clinical investigation is to assess and confirm clinical safety, focusing on minimizing risks, errors, and harm to patients and healthcare providers, such as doctors and nurses. By understanding and learning from past errors and adverse events, clinical trials investigate ways to continuously improve treatment methods.
Another important goal of clinical investigations is to evaluate and verify the performance of a medical device. This involves assessing whether a device functions as intended, and examining its technical, functional, or diagnostic features to ensure it meets its purpose and delivers clinical benefits to patients.
In addition to safety and performance, clinical investigations aim to establish and verify the clinical benefits of a medical device. This means examining the positive impact a medical device can have on a patient’s health, which is measured by meaningful and measurable outcomes that focus on patient well-being.
Clinical trials also investigate side effects, aiming to gather more information about known side effects and identify any previously unknown ones. Overall, clinical investigations are designed to translate scientifically validated innovations into clinical practice, providing patients with new or improved treatments that enhance healthcare outcomes.
Application for Grant of Permission to Conduct Clinical Investigation
Applying for permission to conduct a clinical investigation requires a detailed process to ensure compliance with regulations. A sponsor must submit an application in Form MD-22 to the Central Licensing Authority to begin a clinical investigation.
All investigators involved in the clinical investigation must possess the right qualifications, training, and experience. A qualified physician must be available as an investigator to oversee medical decisions during the investigation.
The laboratories producing clinical data for the clinical investigation must adhere to Good Laboratory Practices (GLP) or hold accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL). This information must be provided to the Central Licensing Authority before the clinical trials investigate the medical devices.
Additionally, sponsors and investigators must be prepared for FDA inspections of clinical investigators, ensuring they meet the required standards and protocols. Adhering to FDA medical device clinical trial regulations is crucial for the approval and successful completion of the investigation.
To conduct clinical trials, pilot or pivotal clinical investigations, the following procedures must be followed to obtain permission:
- Pilot Clinical Investigation: This is the initial phase of testing the medical device on humans. Pilot studies are carried out on a small group of participants to collect preliminary data on the safety and effectiveness of the medical device. These clinical studies aid in understanding how a medical device functions and its safety profile but do not offer sufficient evidence to support therapeutic claims.
- Pivotal Clinical Investigation: This is a more extensive study conducted on a larger group of participants. It aims to gather comprehensive evidence on the medical device’s safety and performance to support the claims made about the medical device.
For medical devices developed in India, the clinical investigation must begin with a pilot study in India. If any design changes occur, medical device manufacturers must follow all activities outlined in EN 62366-1:2015 for the modified parts of the medical device. The process of clinical investigation ensures that medical devices are safe and effective before they reach the market.
Permission to Conduct Clinical Investigation on Medical Device
To start a clinical investigation, a medical device manufacturer must obtain approval from the Central Licensing Authority (CLA). Once all requirements have been met, permission will be granted in the form of MD-23. This authorization allows the clinical investigation to begin based on an approved plan from the Ethics Committee.
Before enrolling the first patient, the clinical investigation must be registered with the Clinical Trial Registry of India. The first patient should be enrolled within a year of receiving the license. If there is a delay beyond this period, additional approval from the Central Licensing Authority will be required to proceed with the clinical investigation.
Retention of records
Every sponsor, Contract Research Organization (CRO), organization, or investigator conducting a clinical investigation must ensure that all data, records, and documents related to the investigation are retained for a minimum period of seven years after its completion. This includes all records from the medical device clinical trial, ensuring that all trial data remains accessible for future review. The relevant authorities may request access to this data at any point during the retention period. Proper documentation and data retention are critical for maintaining compliance with regulations and ensuring transparency in clinical trials in medical devices. Ensuring proper storage of records enables smooth audits and enhances the credibility of the medical device clinical trial process.
