What is a clinical investigation of medical devices?
A clinical investigation of medical devices refers to a systematic study involving human subjects, designed to assess a medical device's safety, performance, or effectiveness. These investigations are essential for regulatory approvals before a device can be marketed. Depending on the jurisdiction's regulatory requirements, they can be either pre-market or post-market studies and often involve comparisons with existing treatments or devices.
What is ISO 14155 clinical investigation of medical devices for human subjects?
ISO 14155 is an international standard that specifies general requirements for conducting clinical investigations of medical devices for human subjects. This standard is designed to protect the rights, safety, and well-being of trial subjects while also ensuring that the scientific conduct of the trial and the credibility of the clinical data are sound. It guides clinical investigations' design, conduct, recording, and reporting. It is particularly crucial for manufacturers looking to comply with regulatory requirements in various countries, especially for CE Marking in the European Union.
What is the purpose of the clinical investigation?
The purpose of conducting a clinical investigation for medical devices is multifaceted and primarily revolves around ensuring that the device is safe and effective for its intended use. Here are the key objectives of conducting clinical investigations:
- Safety Evaluation: The foremost purpose is to establish that the device is safe to use. Clinical investigations help determine if the device poses any risks to patients or users, identifies potential side effects, and measures how significant those risks might be.
- Performance Verification: It’s crucial to verify that the device performs as intended under the conditions of use proposed by the manufacturer. This includes testing the device's functionality and ensuring that it meets the specific claims made by the manufacturer.
- Effectiveness Assessment: Beyond basic performance, clinical investigations aim to confirm that the device effectively achieves the intended medical benefits. This includes demonstrating that the device can improve health outcomes or provide a diagnostic benefit as claimed.
- Comparative Analysis: In some cases, clinical investigations compare the new device to existing treatments or devices to establish superiority, equivalence, or non-inferiority. This comparison can be critical for market positioning and regulatory approval.
- Regulatory Compliance: Clinical investigations generate the necessary clinical data required for regulatory submissions. Successful completion of a clinical investigation is often essential for obtaining approval from regulatory bodies to market and sell the device, especially in stringent regulatory environments like the United States (FDA approval) and the European Union (CE marking).
- Post-Market Monitoring: For devices already on the market, clinical investigations might be conducted to monitor long-term safety and effectiveness, fulfilling post-market surveillance requirements set by regulatory agencies.
What is the difference between clinical evaluation and clinical investigation?
- Clinical Evaluation:
- This is a methodologically sound ongoing procedure throughout the device lifecycle, using scientifically valid data to assess whether there is sufficient clinical evidence to confirm compliance with relevant essential safety and performance requirements. This process involves the assessment of relevant scientific literature related to the device, as well as data concerning safety and performance, including clinical investigation(s) of the device, if available.
- Clinical evaluations are documented in a clinical evaluation report that supports the assessment of the overall benefits and risks of the device and is updated throughout the product’s life cycle.
- Clinical Investigation:
- This is an approach used primarily before the device's wider release, involving specific studies conducted on human subjects to collect data on safety and effectiveness.
- Clinical investigations are controlled, systematic studies involving real patients or users, and are often conducted under regulatory scrutiny to ensure compliance with both ethical and scientific standards.
In summary, while both processes are integral to bringing a medical device to market, clinical evaluation is a broader assessment encompassing all available clinical data including, but not limited to, data from clinical investigations. Clinical investigations, on the other hand, are more focused studies specifically designed to collect primary clinical data from the use of the device.
