ارزیابی بالینی تجهیزات پزشکی

برخی از بخش‌های مهم این الزامات به زبان انگلیسی به شرح زیر است:

Key Excerpts from MDR 2017/745

1. Clinical Evaluation Definition:

   • “Clinical evaluation is a systematic and planned process to collect, analyze and assess clinical data pertaining to a medical device.”

2. General Requirements:

   • “The manufacturer shall perform a clinical evaluation for a medical device as part of the conformity assessment procedure.”

3. Data Collection:

   • “The clinical evaluation shall include a review of relevant scientific literature, existing clinical data, and, where applicable, clinical investigation(s) on the device.”

4. Risk Management:

   • “The manufacturer shall identify and evaluate the risks associated with the device and take appropriate measures to mitigate those risks.”

5. Ongoing Clinical Evaluation:

   • “The clinical evaluation shall be updated throughout the lifecycle of the device, as new clinical data becomes available.”

6. Documentation:

   • “The results of the clinical evaluation shall be documented in a report that is maintained as part of the technical documentation.”

Additional Key Excerpts from MDR 2017/745

7. Clinical Evaluation Plan:

   • “The clinical evaluation plan shall define the strategy and methods to be used for the clinical evaluation, including the collection and analysis of clinical data.”
   • This highlights the necessity for a structured approach to the clinical evaluation process.

8. Clinical Investigation:

   • “If sufficient clinical data is not available, the manufacturer shall conduct a clinical investigation to generate the necessary data.”
   • This establishes the need for new clinical investigations when existing data is insufficient.

9. Benefit-Risk Analysis:

   • “The clinical evaluation shall include a benefit-risk analysis that balances the intended benefits of the device against any potential risks.”
   • This ensures that the advantages of using the medical device outweigh any associated risks.

10. Post-Market Clinical Follow-up (PMCF):

    • “Manufacturers shall establish a post-market clinical follow-up plan to update the clinical evaluation as new clinical data becomes available.”
    • This emphasizes the need for ongoing monitoring of the device’s performance after it has entered the market.

11. Notified Bodies:

    • “The clinical evaluation report shall be made available to the notified body during the conformity assessment process.”
    • This indicates that manufacturers must provide the clinical evaluation report to the relevant authorities for compliance checks.

12. Transparency and Communication:

    • “Manufacturers shall ensure that the clinical evaluation is conducted in a transparent manner and that clinical data is communicated appropriately to relevant stakeholders.”
    • This stresses the importance of transparency in clinical evaluations and the communication of findings.

Summary

The MDR 2017/745 provides detailed guidelines for manufacturers regarding clinical evaluation, emphasizing the importance of evidence-based practices in demonstrating the safety and efficacy of medical devices. The regulation underscores the necessity for ongoing assessment and updating of clinical evaluations to ensure that medical devices remain safe and effective throughout their lifecycle.

Source

For further reading, you can access the full text of the MDR 2017/745 at this link: Regulation (EU) 2017/745 on Medical Devices.

You can find the full text of the MDR 2017/745 at the following link: Regulation (EU) 2017/745 on Medical Devices.

This regulation provides a comprehensive framework for ensuring the safety and effectiveness of medical devices through rigorous clinical evaluation processes.