Get the free Notice of Medical Device Correction - mhra gov

This document is a notice issued by Intuitive Surgical regarding a labeling error on the da Vinci® EndoWrist Stabilizer, instructing customers on how to handle affected products and ensure compliance

How to fill out notice of medical device

How to fill out Notice of Medical Device Correction

1. Identify the medical device that requires correction.
2. Gather detailed information about the correction needed, including the reason for the correction.
3. Complete the header section of the Notice of Medical Device Correction, including device name and manufacturer details.
4. Provide a clear and concise description of the correction, including any risks or adverse effects associated with the device.
5. List the corrective actions that will be taken and the timeline for implementation.
6. Include any instructions for healthcare professionals or users on how to address the correction.
7. Ensure compliance with regulatory requirements and include relevant contact information for inquiries.
8. Review the completed notice for accuracy and clarity before distribution.

Who needs Notice of Medical Device Correction?

1. Manufacturers of medical devices that have identified a need for correction.
2. Healthcare providers who utilize the affected medical device.
3. Patients who may be impacted by the medical device issue.
4. Regulatory agencies that oversee the safety and effectiveness of medical devices.

For pdfFiller’s FAQs

What is Notice of Medical Device Correction?

A Notice of Medical Device Correction is a notification that informs stakeholders, including healthcare providers and the public, about issues related to a medical device that may affect its safety and effectiveness. It is typically issued by the manufacturer or distributor.

Who is required to file Notice of Medical Device Correction?

Manufacturers and distributors of medical devices are required to file a Notice of Medical Device Correction if they identify a problem that could potentially impact the safety or effectiveness of their device.

How to fill out Notice of Medical Device Correction?

To fill out a Notice of Medical Device Correction, one must provide details such as the device identification, the nature and cause of the correction, the potential risks associated with the problem, and the actions being taken to correct it. The form should be clear, concise, and include necessary contact information.

What is the purpose of Notice of Medical Device Correction?

The purpose of the Notice of Medical Device Correction is to ensure patient safety by promptly informing users and stakeholders about identified issues with medical devices, thereby enabling them to take appropriate actions to mitigate risks.

What information must be reported on Notice of Medical Device Correction?

The Notice of Medical Device Correction must report information such as the device name, device identification number, description of the issue, potential risks, corrective actions taken, and contact information for further inquiries.