For the purpose of its risk-based supervision, the Health Care Inspectorate circulates online questionnaires among manufacturers, authorised representatives and resellers of medical devices established in the Netherlands.
The Inspectorate uses the questionnaires to obtain a sharper picture of the market. This includes the class of medical devices made by a manufacturer and the categories of devices the manufacturer places on the market. Additionally, the Inspectorate publishes substantive questions, such as whether the manufacturer has a quality system and whether a risk analysis exists.
The provision of information to the Inspectorate is not voluntary. The power to require information is regulated under various sections of the General Administrative Law Act (Sections 5:16 and 5:17). Section 5:20 of the Act stipulates that a company is bound to fulfil this obligation. The Inspectorate has the power to impose periodic penalty payments as a company fails to cooperate.
Results of earlier questionnaires
The Inspectorate circulated online questionnaires in 2014 and 2015 among manufacturers, authorised representatives and resellers of class I medical devices established in the Netherlands. Online questionnaires were also circulated in 2015 among manufacturers, authorised representatives and resellers of in vitro diagnostic medical devices in the Netherlands.
To view summaries of the results of these online questionnaires (in Dutch only), go to: