I am currently updating our controlled forms relating to Vigilance in accordance with the updated MEDDEV (rev 5). I have access to the standard form for Manufacturers to Report an Incident to the National Competent Authority (section 10.3 of the MEDDEV). However I wondered if anyone had forms they could share detailing

1. Initial Incident reporting that can be completed by the hospital or completed internally if an event is telephoned/faxed/emailed through - this would detail relevant facts about the incident.

2. An Adverse Incident checklist

Many thanks

We incorporate adverse event reporting into our customer complaint process. Each time we receive a complaint, we evaluate it to see if it is a reportable event.

I would define what type of event is reportable in your customer complaint process. You may require several definitions if you have more than one power to answer to (for example, you sel products in Europe & the US).

Each time you think you have a reportable event, I would review the applicable regulations to ensure I have the most up to date information.

Thats interesting - thanks. Our current procedure titled 'Customer Complaints' covers Vigilance but I'd been advised to take it down and make it a separate procedure.

However, it would make things easier if I maintained the current procedure (updated for the latest MEDDEV) and used our Customer Complaint form to get data from the site.


How about a checklist? Would a form running through what constitutes a reportable event suffice?

We don't use a checklist, we just have definitions based upon region. Check out the attached document. Its a comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan. It might help you come up with a general checklist.

What's reportable in one country may not be reportable in one country. For example, if your product is CE marked you may have to report an adverse event even if it didn't happen in Europe.

Can someone help me to find the three adverse incident reporting combined into one process or give me an idea how to generate a document having all the requirement for reporting MDRs in the three different places. I am trying my best but because of all the different definitions I am getting confused.

Mandatory Problem reporting
Adverse Incident reporting'
Vigilance system reporting
Medical device reporting
Canadian Medcial device reporting
Adverse reaction reporting and so on......

Please Help.

If someone has a template then could they share it here.....

Was hoping to find some response here..seems that I cannot....

Can someone help me to find the three adverse incident reporting combined into one process or give me an idea how to generate a document having all the requirement for reporting MDRs in the three different places. I am trying my best but because of all the different definitions I am getting confused.

Mandatory Problem reporting
Adverse Incident reporting'
Vigilance system reporting
Medical device reporting
Canadian Medcial device reporting
Adverse reaction reporting and so on......

Please Help.

If someone has a template then could they share it here.....

You can have a single integrated procedure for medical device Reporting and vigilance. But you have to make clear definitions such as MDR- Reportable Event, serious injury, Vigilance system, incident, near incident, competent authorities, and notified body to avoid confusion between different regulatory terminologies.

Under the single topic “Procedure for Medical device reporting and vigilance", you need to make clear procedure for each regulatory requirements.

For better understanding prepare a table, in that explain time lines for reporting FDA, EU and Canadian regulatory bodies.

Also, please mention the current and relevant regulatory guidelines information in to the reference material or associated material section.

Regards
S. Subramaniam

Hi CBAL08,

See if the attached are any help.

Steve

Hi CBAL08,

See if the attached are any help.

Steve

Thank you for the forms Provided Steve. I also mjst thank you for posting other documents in Elsmar as they seem to be very sueful for people like me who are new in the field of Quality.

However was trying to write the Adverse incidence reporting for US, EU and Canada in One and that is what is making me go crazy.....trying to tabulate but is not helping much at the moment. Will try to read through the regulations and guidelines for all quitely first in the weekend and then will try to write up a combined procedure.

Thank you for your support.

:thanx:

You can have a single integrated procedure for medical device Reporting and vigilance. But you have to make clear definitions such as MDR- Reportable Event, serious injury, Vigilance system, incident, near incident, competent authorities, and notified body to avoid confusion between different regulatory terminologies.

Under the single topic “Procedure for Medical device reporting and vigilance", you need to make clear procedure for each regulatory requirements.

For better understanding prepare a table, in that explain time lines for reporting FDA, EU and Canadian regulatory bodies.

Also, please mention the current and relevant regulatory guidelines information in to the reference material or associated material section.

Regards
S. Subramaniam

Thank you for the guidance. I am trying my best. AND FOR PROCESSING the reports further I have placed the links to to form and am trying to explain for each regulatory bodies separately.

As suggested have the definitions clearly outlined in the definitions section of the SOP.

Have tabulated the terms and the time scale and applicability in the table.

Need to sit quitely and see if the whole document makes sense or not?

Thank you once again.:thanks: