Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances.

Medical Device Reporting

Medical Device Reporting and handling of recalls are very important to the medical device industry. MDR is the FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities. The point of having such a mechanism in place is that adverse events can be detected and corrected quickly. Medical device manufacturers need to be familiar with the finer aspects of the MDR. Apart from medical device manufacturers; user facilities such as hospitals and nursing homes are required to report suspected medical device related deaths to both the FDA and the manufacturers.

Recall

Recalls constitute another crucial component of the complaint handling system. Medical device reporting and handling of recalls complement each other, as can be seen from an understanding of this exercise.

A recall is a process by which a medical device is removed from the market or corrected whenever the FDA finds that there is a reasonable possibility that the device could cause any of these: serious, adverse health consequences or death. The link between medical device reporting and handling of recalls assumes greater significance when one considers what a recall means. In simple terms, it is an action taken to address a problem existent in a medical device that violates FDA regulation.

Recalls can happen in any of these three situations: a) when a medical device comes with a defect, b) the possibility that it could pose a risk to health is probably high, or c) there exists a combination of these two. Different rules for recall exist for different classes of medical devices. It is imperative for manufacturers to be familiar with these.

Thus, medical device reporting and handling of recalls constitute a core element of safety.

GlobalCompliancePanel

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