Materiovigilance (also known as medical device vigilance) refers to the monitoring and reporting of adverse events or incidents related to medical devices. It involves collecting and analyzing information on the safety and performance of medical devices in order to identify potential risks, prevent harm to patients, and improve the overall quality of healthcare.
Monitoring adverse events and incidents related to medical devices
Conducting investigations into adverse events to identify the cause and prevent future occurrences
Ensuring compliance with materiovigilance regulations and standards.
Reporting adverse events to regulatory authorities
What is a Complaint:
FDA provides a precise definition of complaint in the section 21 CFR 803 (b):
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
The key characteristic for a complaint is the presence of an allegation against a specific device. This is very important as it will be useful to determine if a specific communication received from the customer can be considered a complaint or not.
It is essential to collect all the necessary information to perform an adequate evaluation of the reportability of the event.
In another article, we have discussed the techniques for root-cause analysis. In the context of complaint handling, technical investigation can be quite different depending on the type of events and type of potential failures. However, in general, technical investigation may contain the following items:
Once the root-cause of the event is determined, it is important that a risk assessment is performed to ensure the risk is considered acceptable. Unacceptable risks for a marketed medical device necessitate field safety corrective action or field safety notice to be implemented.
Response to customers with a summary of the complaint received and the results of the investigation shall be provided under the following situations:
Research – including:
Requisite MDR PMS Revisions: