Get the free Medical Devices Vigilance System (MEDDEV 2 - ec europa

Ref. Ares(2018)5672027 06/11/2018Manufacturers Periodic Summary Report (PSR) Medical Devices Vigilance System (MEDLEY 2.12/1 rev 7) v.12/11 1. Administration Information To which NCA(s) is this report

How to fill out medical devices vigilance system

How to fill out medical devices vigilance system

1. Step 1: Collect all the necessary information about the medical device, such as product name, model number, and manufacturer details.
2. Step 2: Identify the adverse event or incident that has occurred with the medical device.
3. Step 3: Fill out the appropriate forms provided by the medical devices vigilance system. This may include incident report forms or adverse event report forms.
4. Step 4: Provide detailed information about the adverse event or incident, including date and time of occurrence, description of the event, and any known contributing factors.
5. Step 5: Attach any supporting documentation, such as medical records or images, if applicable.
6. Step 6: Submit the filled-out forms and supporting documentation to the designated authority or regulatory body responsible for the medical devices vigilance system.
7. Step 7: Follow any additional instructions or requirements provided by the authority or regulatory body, if necessary.
8. Step 8: Keep a copy of the filled-out forms and supporting documentation for your records.
9. Step 9: Monitor any further communication or feedback from the authority or regulatory body regarding the submitted incident or adverse event report.

Who needs medical devices vigilance system?

1. Medical device manufacturers need the medical devices vigilance system to track and monitor the safety and performance of their products.
2. Regulatory bodies and authorities responsible for overseeing medical devices need the system to receive and analyze incident reports and adverse events related to medical devices.
3. Healthcare professionals and practitioners who use medical devices need the system to report any adverse events or incidents they encounter during clinical practice.
4. Patients and healthcare consumers benefit from the system as it helps ensure the safety and effectiveness of medical devices used in their care.
5. Researchers and scientists may also utilize the system to study trends and patterns related to medical device safety and performance.

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What is medical devices vigilance system?

The medical devices vigilance system is a system for monitoring and reporting incidents and risks associated with medical devices.

Who is required to file medical devices vigilance system?

Manufacturers, authorized representatives, and importers are required to file medical devices vigilance system.

How to fill out medical devices vigilance system?

Medical devices vigilance system can be filled out online through the designated regulatory authorities' portal.

What is the purpose of medical devices vigilance system?

The purpose of medical devices vigilance system is to ensure the safety and effectiveness of medical devices in the market.

What information must be reported on medical devices vigilance system?

Information such as incidents, complaints, and risks associated with medical devices must be reported on medical devices vigilance system.