Our supervision of medical technology
General overview of the supervision in the Netherlands.
Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. Innovative technologies are rapidly being developed to improve care. Increasingly, medical technology determines the quality of care.
What are medical devices?
Medical devices are used for diagnosis or treatment purposes in the healthcare sector. Examples include implants such as pacemakers or prostheses, medical equipment such as MRI scanners, ventilators or surgical instruments, but also may include software, such as a medical app on a smartphone.
In vitro diagnostic medical devices
In vitro diagnostic medical devices (IVDs) constitute a separate group of medical devices. They are tests that help to identify diseases, disorders or abnormalities. IVDs are used at different times in the care process. They help doctors to make a diagnosis. Special laboratories, such as those in hospitals, are important users of IVDs. But general practitioners also use IVDs in their practice, for example to examine urine for an infection. There are also IVDs that a person can use at home. Examples include a pregnancy test and a blood glucose meter.
Surveillance of the safety of medical technology
Medical technology and its application open up opportunities. Innovations result in new treatment methods that serve the interests of the patient. At the same time, medical technology also involves risks. The risks must be identified and controlled as much as possible.
The basic principle is that there must be a good balance between the health benefits of the technology and the risks posed by its application. Risks always exist and there is never a 100% guarantee of safety.
The Health Care Inspectorate arranges its supervision to address the greatest risks for patient safety and their early identification. For this purpose the Inspectorate acts on signals received from members of the public, manufacturers, health care providers and other parties.
We monitor and advance optimum safety of medical technology and its application so as to enhance the quality and safety of care provided to members of the public. To achieve that end, we monitor and supervise the safety of medical devices and IVDs, as well as their safe use by healthcare providers. Our perspective is based on the entire life-cycle of the medical technology, in which the following subsequent phases can be identified, as also presented in the figure:
- Market introduction
- Selection & purchase
- Clinical use
- Post market surveillance (PMS)
The supervision of medical devices and IVDs is subject to European legislation, which means that the Health and Youth Care Inspectorate collaborates with other countries. See: The European MDR and IVDR regulations. We:
Post-market surveillance (PMS)
Post-market surveillance (PMS) is a collection of activities which the manufacturer has to carry out in order to monitor the safety and performance of its product once it has been launched onto the market. The aim is for the manufacturer always to have up-to-date information to provide a basis for improving the product or its safe usage wherever necessary.
It is essential that manufacturers carry out PMS in order to guarantee the quality and safety of medical devices and IVDs. The PMS requirement has been fleshed out in great detail in European legislation. The manufacturer is obliged to verify whether the performance of the device meets the requirements for quality and performance, in other words, whether the product does what it has been made for and can be safely used.
The experiences of care professionals and/or patients with using the device can provide a basis for further investigation by the manufacturer. This may mean that the manufacturer then need to take necessary corrective or preventive measures.
How do we supervise PMS? For more information, see: supervision of post-market surveillance
Safe use of medical technology
Safe medical products are needed to provide safe care. However, the products in question also have to be used properly. Obviously they are supposed to improve people's health, but inexpert use and inadequate risk assessment may result in in serious patient harm to health. That is why we monitor the entire life cycle chain of medical technology, from the authorisation of a medical device or IVD through to its safe use by heathcare professionals.
The Healthcare Quality, Complaints and Disputes Act [De Wet kwaliteit, klachten en geschillen zorg, Wkkgz) and the Individual Healthcare Professions Act [Wet op de beroepen in de individuele gezondheidszorg, Wet BIG) are the most important legal frameworks for the safe use of medical technology.
Examples of how safe use is monitored are the supervision of IGJ on the Covenant on Medical Technologies (Convenant medische technologie) and on eHealth and on medical implants (in Dutch).
Our supervision may reveal that medical devices fail to observe all relevant legislation. Where this is found to be the case, we will take measures to ensure compliance with legislation.
Our supervision and enforcement are based on Dutch and European legislation. We may take a variety of measures in the field of medical devices.
The Medical Devices Act empowers the Inspectorate to impose administrative measures. We may:
- issue an order: to prevent harm to public health, the Inspectorate may order the suspension or termination of the trading, importing, exporting or delivery of a medical device, and may also order the withdrawal of a medical device from the market;
- impose a periodic penalty payment : we may impose a periodic penalty payment to enforce an order, or to obtain cooperation in the supervision conducted by the Inspectorate;
- impose an administrative fine: we may impose an administrative fine for failure to comply with legislation governing medical devices. An administrative fine will reflect the circumstances of the case and may be set at an amount up to €450,000. The Minister of Health, Welfare and Sport has laid down the Policy Guidelines on Administrative Fines for the imposition of administrative fines. In some cases, we may first issue a warning instead of an administrative fine. This subject is also covered in the policy guidelines.
Measures under criminal law
Some breaches of legislation covering medical devices are economic offences. Where economic offences occur, the Inspectorate may call in the Public Prosecution Service after consultation. The Public Prosecution Service may institute criminal proceedings.