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Adverse Event Reporting

The FDA regulation is called the MDR (Medical Device Reporting), and European Competent Authorities (such as the German Ministry of Health and British Department of Health) call their regulation Vigilance Reporting.  Now HealthCanada and the Australian TGA have issued their own adverse event reporting requirements in their recently revised regulation.

The FDA and EU Competent Authorities have agreed to exchange adverse event reports as part of a Mutual Recognition Agreement (MRA) agreed to in 1998.  As such, medical device companies are expected to report adverse events as well as "near misses" -- potential adverse events which might occur -- to both FDA as well as the appropriate European authorities, if the product is CE Marked and distributed to at least one EU member state.

The CRO Group can help you convert a US system so that it complies with the Australian, Canadian, and EU reporting requirements whether you currently do this manually, with a purchased software program, or a "home brewed" one.

As with the USA reporting requirements, specified in 21 CFR 803, for the Australian, Canadian, and EU, there are several forms and reports which need to be submitted whether you have an adverse event or not in that region or country.  The most important aspects of adverse event reporting compliance comes when you are made aware of an unfortunate adverse event involving your product, and then much later, when you have another similar product you are trying to get registered, and there is evidence of adverse event reporting nonconformity with one of the regulatory agencies.  To stay on the conforming side with your adverse event reporting, click here.

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