Malfunctions, 2 year History, and Medical Device Reporting
Hello All,
I have a question regarding 2 year history of malfunctions to help determine an MDR or MPR (US and Canada respectively).
In short, a complaint comes in to the company, the complaint is processed and triaged to Quality to determine types of investigations, if it's a potential reportable event, then the complaint is forwarded to the Vigilance Dept for medical assessment and submission, if necessary. The Vigilance group who maintains the AE database (while the Quality group maintains the complaints database) is asking how they can handle malfunctions. How do most companies handle this 2 year history to determine the malfunction has not occurred in the past 2 years? Is it possible to code malfunctions to MedRA terms? How will the vigilance team know if the occurence is a malfunction? I feel as though Quality should dictate this when sending to Vigilance?
Background: We are a mainly a pharma company so devices are new to us.
Thank you
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