How the IGJ responds to reports
A manufacturer or its authorised representative is legally obliged to report serious incidents and corrective actions with medical devices. In addition to these reports, the IGJ receives reports from the public, care professionals and distributors.
Reports are an important source of information for monitoring purposes
Reports are an important source of information for the Inspectorate. Each report is assessed separately, along with any additional information which might be available.
The Inspectorate monitors the safe operation and use of medical devices and in that context it is also important to weigh up the risks and benefits. After all, there is always a risk, for example the possibility of a complication or an incident when using a medical device. The expected benefits of using the medical device must outweigh any risks that exist.
Manufacturer responsible for safe product
Manufacturers are themselves responsible for properly weighing up their product's advantages and disadvantages and its safety. The European regulations oblige them to carry out post-market surveillance (PMS). PMS is a collection of activities which manufacturers have to carry out in order to monitor the safety and performance of the product they are selling. Manufacturers are obliged to implement improvements if that is necessary for safety reasons.
The Inspectorate can initiate an investigation or take enforcement measures as a result of reports.
How can I report?
The way you report depends on your role:
• Reporting as a manufacturer/authorised representative of medical devices
• Reporting as a member of the public (in Dutch)
• Reporting as a care professional or distributor (in Dutch)