The Danish Medicines Agency is requiring some devicemakers to report non-serious as well as serious adverse events relating to their products.
Previously, only serious events needed to be reported. Under the new rules effective March 3, all incidents must be reported if the agency imposes enhanced reporting requirements on a particular type of device.
The agency said it may impose the expanded requirements if it needs to know more about potential failures, errors or deficiencies.
The agency said it wants to ensure that all incidents are investigated fully before any corrective actions are taken, such as changing the construction of the device, the production method or the instructions for use.