The Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd] (IGJ) supervises the performance, safety and safe usage of medical devices and in vitro diagnostics devices (IVDs). Medical devices and IVDs play an essential role in healthcare. At the same time, the use of medical devices entails certain risks, as undesirable effects may occur at all times – even in the case of devices that comply with all the rules. The basic principle is that there should be a good balance between the health benefits and the risks inherent in the use of medical devices.
The purpose of the supervision is to make sure that patients experience as few as possible, and preferably no detrimental consequences, when as a result of the use of medical technology. This applies both to normal use and use within clinical trials. Manufacturers must therefore endeavour to minimise the risk of incidents occurring. The Inspectorate alongside other European authorities is responsible for supervising this process.
We do this by, for example, conducting inspections at manufacturers, authorised representatives, importers and distributors of medical devices and in vitro diagnostic devices. The inspections serve to verify that they are in compliance with the legislation.
How do we carry out our supervisory tasks?
Supervision of risks
Every year the IGJ decides which economic operators, product groups or processes require extra attention.
In 2022 these were:
- Authorised representatives
- Manufacturers who recently placed a medical device or IVD on the market
- Medical devices for people with a disability (class I medical devices)
- Medical devices that fall under the transitional provisions of the MDR
- Post-market surveillance
- Clinical evaluation
However, this does not mean that these are the only reasons for carrying out inspections. The list can also change during the year.
Supervision of incidents
Incident reports and reports on corrective actions in relation to problems with a medical device are a crucial source of information for the Inspectorate. This is also referred to as vigilance. Whenever there is cause to do so we carry out inspections based on notifications we receive from economic operators, care institutions or the general public.
European legislation requires European Member States to work closely together. Reports from other European Member States are likewise a reason for us to conduct an inspection. We are also increasingly carrying out inspections in close cooperation with supervisory authorities from other EU Member States.
An inspection can take place on site but the IGJ also has the option of requesting documentation (a desk inspection) or of carrying out the inspection remotely (online).
During an inspection, we review the legal requirements that apply to the economic operator and/or the medical device.
In the majority of cases we do not assess on all the legislation during an inspection. Instead we focus on certain elements, depending on the reason for the visit.
After an inspection we provide feedback on the results to the economic operator. In the first instance this is done in the form of a draft report which is submitted in order to check for any incorrect facts. After we have received a response, or after the stated deadline has passed, the economic operator will receive the definitive report, including the conclusion.
We take action if we find that an economic operator is not in compliance with the rules. The measure imposed by the Inspectorate depends on a number of factors, including the risk to patients of the violation non-conformity identified.
Please find out more about the various measures we may take (in Dutch).
In April 2021, the Health and Youth Care Inspectorate adopted a new intervention policy regarding the MDR and IVDR Regulations. This MDR/IVDR intervention policy (in Dutch) is in line with the requirements of these regulations. For more information, please go to the section on Supervision and Enforcement of the MDR and IVDR (in Dutch).