Solid product certifications
Solid system certifications
Manufacturers themselves are responsible for properly monitoring these risks and benefits and ensuring product safety. Following some reports, the inspectorate conducts an investigation or takes enforcement measures.
Healthcare professionals and/or patients
Experiences of healthcare professionals and/or patients when using the product may be a reason for further investigation by the manufacturer. This may mean that the manufacturer must then take necessary corrective or preventive measures.
Vigilance (monitoring) means the activities associated with detecting, assessing, understanding and preventing harmful side effects of medical devices. Vigilance is part of post-market surveillance.
In the Netherlands
The Healthcare and Youth Inspectorate (IGJ) assesses the extent to which manufacturers implement PMS and whether that complies with legislation.