FREQUENTLY ASKED QUESTIONS

This platform focuses on the mobile health applications that are CE-marked medical devices. While your app may have health benefits for its user, this is not the platform where such apps are reviewed and published.

The ‘intended use’ is especially important in the definition of a medical device. A medical device is defined as: “instruments, apparatus, appliances, materials or other articles, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
– investigation, replacement or modification of the anatomy or of a physiological process,
– providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:
– devices for the control or support of conception;
– products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”

In summary:

  • Does my health application help prevent an illness, injury or disability?
    If yes → medical device
  • Does my health application diagnose an illness, injury or disability?
    If yes → medical device
  • Does my health application provide a prognosis of an illness, injury or disability?
    If yes → medical device
  • Does my health application send data to my health care provider to monitor an illness, injury or disability?
    If yes → medical device
  • Does my health application suggest some type of treatment for an illness, injury or disability?
    If yes → medical device
  • Does my health application provide some type of alleviation of an illness, injury or disability?
    If yes → medical device
  • Does my health application provide some type of information via in-vitro study of a human specimen?
    If yes → medical device

In case of doubt, it is advisable to consult the Federal Agency for Medicines and Health Products (FAMHP).

Before a medical device, including a health application, can be launched on the European market it has to bear the CE-marking. The CE marking indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. It indicates that the medical device meets the EU legislation requirements. A medical device that bears the CE marking can move freely within the European market.

EXCEPTION: Custom-made devices, system and medical treatment packages, medical devices for clinical studies and IVDsintended for performance studies do not require CE marking. Other procedures are applicable. For more information refer to the website of the Federal Agency for Medicines and Health Products (FAMHP).

The Federal Agency for Medicines and Health Products (FAMHP) is the regulatory authority responsible for market surveillance in Belgium. The FAMHP checks, among others, whether medical devices offered (for sale) in Belgium actually bear the CE marking and meet all the applicable requirements. The authorisation is recorded in the Royal Decree dated 18 March 1999 regarding medical devices, the Royal decree dated 15 July 1997 regarding active implantable medical devices and the Royal Decree dated 14 November 2001 regarding medical devices for in vitro diagnostics.

Medical devices are classified into four groups (class I, IIa, IIb and III) based on the risks of use. The risk of class I medical devices is the lowest. This influences the CE marking procedure:

  • A self-certification process, a simplified procedure, is sufficient for class I medical devices.
  • The manufacturer of class IIa, IIb and III medical devices has to submit its product for certification by a Notified Body.

In general, software to monitor physiological processes is a class IIa product, unless it is intended to monitor vital physiological processes and should the type of variation of these parameters be such that the patient may be in immediate danger in which case the device is a class IIb medical device.

All other software is, in principle, a class I medical device.

For more information on the risk classification, refer to the FAMHP website: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/classification

In case of doubt, please refer to a notified body or the FAMHP for advice.

CE marking of class I medical devices is not obtained through a notified body but through a simplified procedure called self-certification. The manufacturer applies the CE marking for which only the manufacturer is responsible. When your product does not have to be inspected by a notified body, the product is tested by the manufacturer to check whether it meets the technical requirements. Testing consists of assessing and documenting the potential risks when using your product. For more information regarding self-certification and registration with the notified body, please refer to the FAMHP website: https://www.fagg.be/nl/MENSELIJK_gebruik/gezondheidsproducten/medische_hulpmiddelen_hulpstukken/informatie_fabrikanten/medische_hulpmiddelen_klasse_I

The manufacturer has to submit their product to a notified body, authorised by the competent authority of the member state where the manufacturer is established and registered with the European Commission to apply for CE marking for class IIa, IIb and III medical devices. When a notified body has participated in the conformity assessment, a four-number identification code is added after the CE marking when issued. CE marking which has been obtained through the simplified self-certification procedure does not include an identification code. The certification of conformity issued by a notified body is valid for a period of no more than five years. For more information on this type of CE marking, refer to the FAMHP website: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

Note: Whether your health application bears the CE marking via the simplified self-certification procedure or via a notified body, you always have to draw up a technical dossier containing all documents demonstrating that your product meets the technical requirements.

The CE marking itself has to be applied in such a manner that it is visible, legible and permanent on the medical device, the packaging and the operation manual insofar technically possible and appropriate. When a notified body is involved in the assessment procedure, the identification number for the notified body has to be indicated alongside the CE marking.

Note: You also have to set up and sign an EU declaration of conformity stating that your product meets all legal requirements.

Please refer to the European Commission’s Blue Guide for more information on CE marking in general.

Applying for funding is reserved for applications which have proven clinical and health economic benefit/added value. These applications must also meet all level 1 criteria and the (applicable) level 2 criteria. A funding procedure is in development by the NIHDI (Belgian National Institute for Health and Disability Insurance (RIZIV/INAMI)) for mobile health applications that have the clinical and health-economic data available to support such a funding request. Level 3 provides information on the status (submitted, accepted for review, approved, declined) of the NIHDI funding request and on the timelines of the procedure.

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