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 defined as products used for diagnosis or treatment in the health care sector, with the exception of medicines. Examples include implants like pacemakers or prostheses, surgical instruments and MRI scanners, but also a blood glucose meter for home use or 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.
Supervision to address the greatest risks
Medical technology and its application open up opportunities. Innovations result in new treatment methods that serve the interests of the patient. Medical technology also involves risks. The risks must be known and they must be controllable.
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.
The Health and Youth Care Inspectorate monitors and promotes optimum safety of medical technology and its application so as to enhance the quality and safety of care for members of the public. To accomplish this goal, we maintain supervision over the safety of medical devices, but also over their safe use by heath care 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)
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.
The European directive (93/42/EEC) states that a manufacturer is responsible for monitoring the performance of the delivered product.
The manufacturer is obligated to check whether the performance of the product meets the requirements for quality and safety, 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 product 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
The supervision of medical devices is subject to international legislation, so we cooperate with other countries. We are an active member of EU committees and working groups involved in the assessment and development of medical devices regulation on the market.
We check whether manufacturers and suppliers of medical devices are complying with the rules and laws and take action when breaches occur. We evaluate received reports of problems with medical devices and again take action when breaches occur. We also maintain supervision over notified bodies established in the Netherlands.
Safe use of medical technology
A safe medical product is required to provide safe care. But a safe medical product does not necessarily translate into safe care. Injudicious use and inadequate risk assessment may result in serious harm to health instead of the intended goal of health enhancement. Our supervision maintained over medical technology therefore embraces the entire life cycle: from market introduction of a medical device up to and including its safe use by care providers.
National legislation covers the provision of medical care (and thus the application of medical technology). This legislation is widely framed (defining what must be achieved rather than how) and is often further elaborated through professional standards.
An example of supervision of the safe application of medical technology is the surveillance on the Medical Technology Covenant (Dutch) and on eHealth.
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.