Medical Device Incident Reporting: Why Manufacturers Need to Be more Aware

The Dutch Health and Youth Care Inspectorate (the Inspectorate) suggests manufacturers be more aware of medical device incident reporting.  In response, the Inspectorate has implemented a new automated alert system.

A brief summary of the new medical device incident report system

To enhance incident reporting compliance, the Inspectorate created an alert system that aims to identify incidents that are reported late, as required by the timelines stated in Article 87 and Article 82 of the MDR EU 2017/745 and IVDR EU 2017/746, respectively. These deadlines are specifically related to reporting serious incidents and field safety corrective actions.

The future of handling potential violations

To mitigate potential violations of the law, the Inspectorate has planned several measures for the upcoming year, which may include the issuance of penalties for non-compliance. It is crucial, therefore for manufacturers, to strictly adhere to the specified deadlines mentioned above for reporting vigilance cases in order to avoid facing these consequences.

Medical device incident reporting with MedEnvoy

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