Medical devices are products which are covered by the Medical Devices Act. In practice, this comes down to all the equipment, software and consumables which are used in healthcare, with the exception of medicines. The National Institute for Public Health and the Environment (RIVM) performs laboratory and desk research (eg. literature research and reviews of manufacturers’ product files) for medical devices, with patient safety as the primary focus.
Medical devices are products which are used for the prevention, diagnosis, treatment and monitoring of a disease or disability. Examples range from surgical instruments and high-tech equipment like MRI scanners to accessories or software which are needed for the correct use of a medical device.
Medical devices are divided into four classes, namely class I, IIa, IIb and III. The higher the risk of problems with a medical device leading to unsafe situations for the patient, the higher the class to which the medical device is assigned. The requirements are stricter for medical devices of a higher class compared to those in a lower class. Examples of medical devices are wheelchairs and plasters (class I), MRI scanners (class IIa), dialysis systems (class IIb) and hip implants (class III).
RIVM carries out different activities with respect to medical devices. Our main focus is on high-risk medical devices. Patient safety is the primary focus of our activities. RIVM conducts both laboratory and desk research. The latter consists of, for example, literature research and reviews of manufacturers’ product files. RIVM also takes part in national and international committees related to medical devices where it contributes from the perspectives of both content and strategy. This work is usually commissioned by other government institutions like the Ministry of Health, Welfare and Sport (VWS) and the Health Care Inspectorate (IGZ). VWS determines policy on medical devices and the IGZ monitors the medical devices. RIVM supports both VWS and IGZ in their activities.
An implant is a medical device that is implanted in the body for medical or cosmetic purposes. These implants can potentially cause undesirable effects or complications. These complications can be reported to the Notification Point Complications of Implants. Health complaints potentially related to implants are forwarded to the Expert centre Complications of Implants which consists of experts from RIVM and Lareb. The expert centre analyzes and interprets these complications, after which they are interpreted together with medical experts from the field as necessary. It is important that complications are reported so that problems with a specific implant are quickly identified. Problems with a specific implant will be shared with IGZ so that they can take any necessary measures. Reports on these specific problems will also be published on the webpage www.meldpuntbijwerkingenimplantaten.nl. On this webpage, you can also report complications potentially related to an implant using the designated form.