Some eHealth products have a specific medical goal, such as facilitating diagnostic and treatment processes or patient monitoring. These products may be subject to the Medical Devices Act. In that case, the manufacturer of the product is subject to the IGJ’s supervision and must ensure that its product is safe.
The IGJ’s supervision includes responding to reports/notifications and carrying out inspection visits at manufacturer sites. The Inspectorate can take action if a manufacturer does not comply with the rules of the Medical Devices Act (Wmh). In that case, the Inspectorate can impose a warning, penalty or a different measure.
Not every software application or other example of eHealth is a medical device. For example, step counters and other recreational health apps, are not medical devices. These are therefore not subject to the IGJ’s supervision.
Software as a medical device
A software product can be a medical device if it has a diagnostic or therapeutic function. It is quite obvious for software that is part of a medical device, but not so obvious for standalone software.
For example, an MRI scanner, a medical tool for making photographs of organs and tissues, contains software for the proper operation of the device.
Software that is not part of a medical device (stand-alone software) can also be regarded as a medical device. For example a software product used to display the MRI images for a caregiver or a product that uses the medical data of a patient to identify a condition or disease.
Since 2014, the IGJ has enforced the relevant regulations if software manufacturers violate the provisions of the Medical Devices Act. In actual practice, risk analyses and clinical evaluations often turn out to be weak points at the manufacturers visited by us.
The new European regulations for medical devices and IVDs also introduce changes for software that is considered to be a medical device. For example, the risk class of software can change, which can result in a change in the procedures that need to be followed. There are also specific rules and regulations for software as a medical device and for Medical Device Software. For more information on this topic, please consult the following links:
- New European Regulations for medical devices and IVDs- English
- When is software subject to the new European regulations for medical devices?
- Medical Devices Regulation:
EUR-Lex - Document 02017R0745-20200424 (europa.eu) - English
- In-Vitro Diagnostic Regulation:
EUR-Lex - Document 02017R0746-20170505 (europa.eu) - English
- Various guidance documents for the MDR and IVDR:
European Commission Medical Devices Guidance - English