In order to ensure that medical devices distributed to the market remain safe and perform as intended, adverse events or incidents are reported to the appropriate Regulatory Authorities. In Europe, this system is known as the vigilance system. In the U.S., this activity is known as Medical Device Reporting (MDR). Regulatory authorities share information, thus ensuring public safety and maintain the right to initiate a mandated recall of medical device product when a risk to public safety has been determined. Medical device industry organisations must be aware of their role and responsibilities related to vigilance and MDR.
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