Ensure Regulatory Compliance

Making available medical devices on global markets is hardly ever without risk. Where medical devices are crucial to supporting diagnostics and treatment of patients, at the same time they may introduce safety risks. Such risks may lead to unexpected or expected patient harm.

Manufacturers need to have a medical device vigilance reporting system in place, which depending on the regulatory jurisdiction and their regulations may require direct reporting to the regulatory authorities.

Reporting of such ‘adverse events’ must be done without undue delay, and often within stringent specified timelines. EU MDR vigilance reporting is crucial to ensure that the safety and performance of medical devices can be monitored by regulators. The lack of proper reporting may lead to potential penalties and market withdrawal issued by regulatory authorities.

Medical device vigilance reporting does not necessarily mean that a manufacturer claims that the adverse event is caused by the medical device, especially if an adverse event and its root cause and risks haven’t been investigated thoroughly yet. Therefore it is important to provide the relevant information to the authorities at the right moment in time. Reporting obligations may also apply to other parties in the economic operator chain (e.g. importers, authorised representatives and distributors).

Regulatory authorities have their own reporting templates and portals which must be used by the manufacturer. Recently, we have seen the increased use of the adverse event terminology published by the IMDRF, a framework that can support the MDR vigilance reporting guidance and can be aligned with the risk assessment of the manufacturer.