Glossary

Legal basis

Note: the MDR and IVDR are not the only legal bases for regulating devices.  More information on the legislation governing devices is available on this page.

Common words

  • Devices: this word refers to all medical devices, custom-made medical devices, in vitro diagnostic medical devices, their accessories and certain products without an intended medical purpose. More information on the different types of device is available on the page "What is a device?".
  • Intended purpose: use of the device as intended by the manufacturer. This information is provided, where applicable, on the label, in the instructions for use, or in other sources (e.g. advertising on the manufacturer's website).
  • (CE) marking of conformity: a symbol guaranteeing the device's conformity with the requirements of the applicable regulations (MDR or IVDR). The manufacturer affixes the CE marking to the device or, if necessary, to its packaging. The marking is also affixed to the instructions for use and the sales packaging, where applicable. More information on the CE marking can be found on our website.
  • Pharmacological, immunological or metabolic means (words present in the definition of a medicinal product and a medical device).

    • "Pharmacological means" refers to the influence of a substance on a part of the human body. This substance can, for example, block, improve or reduce a function in the body. For example, a medicinal product for a headache acts on the nervous system to relieve pain.
    • "Immunological means" refers to the reaction triggered by a substance in the human body, involving the immune system. For example, when a vaccine is administered, it stimulates the immune system.
    • "Metabolic means" refers to the actions of a substance on a biochemical process in the human body. For example, a substance may block the secretion of gastric fluids during digestion to prevent heartburn.
  • Instructions for use: support adapted to the device to inform the user of the device's intended purpose, its proper use, any precautions to be taken and any other relevant information.
  • Lay person: an individual who does not have formal education in a field of healthcare or medicine.
  • Traceability: the ability to locate a product and retrace the path it has taken (in the factory, but also from the factory to the user). More information on device traceability is available on our website.
  • User: any person (patient or healthcare professional) who uses a device.

Economic actors/operators

  • Competent authority: organisation defined by each European Union (EU) Member State to carry out a series of tasks set out in Regulations (EU) 2017/745 and (EU) 2017/746 (market surveillance, vigilance, etc.). In Belgium, the Federal Agency for Medicines and Health Products (FAMHP) is the competent authority.
  • Distributor: any (natural or legal) person in the supply chain that makes a device available on the EU market, up until the point of putting it into service. The manufacturer and importer are not considered distributors.
  • Health institution: an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
  • Manufacturer: a (natural or legal) person who manufactures (or fully refurbishes) a device and markets the device. A manufacturer is also someone who has a device designed, manufactured or fully refurbished by someone else (a third party), but sells it under their own name or trade mark.
  • Importer: any (natural or legal) person established within the European Union that places a device from a third country on the European Union market.
  • Investigator: healthcare professional responsible for the conduct of a clinical investigation or of performance evaluations within the institution where they are carried out.
  • Authorised representative: if the manufacturer is not located in the European Union, they must be represented by a third party (natural or legal person). This third party is called the authorised representative. They carry out the tasks described in a mandate, which is a contract between the authorised representative and the manufacturer.
  • Notified body: an independent body designated under the MDR or IVDR Regulations, whose intervention may be required in the conformity assessment process for devices.
  • Subject: an individual who participates in a clinical investigation or performance study for which the device is tested on the person or on their body specimens.
  • Sponsor: any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation or performance study.

Life cycle

Devices undergoing clinical investigation or performance studies

For medical devices and in vitro diagnostic medical devices

  • Clinical benefit: the positive impact of a device, in the context of the manufacturer's intended use, on the health of an individual or on public health (e.g. screening for a disease, treating cancer, reducing the risk of transmitting a virus).
  • Performance: the ability of a device to be used in accordance with its intended purpose as stated by the manufacturer. For in vitro diagnostic medical devices, this is their ability to produce results related to a given disease or medical condition, depending on the intended users (professional or otherwise).
  • Clinical evidence: all clinical data and results from a device which must be of a sufficient quantity and quality to determine the safety and benefits of the device (provided it is used in accordance with the manufacturer's instructions).

For medical devices

  • Clinical investigation: any investigation involving one or more human subjects to assess the safety or performance of a device. This is the equivalent of clinical trials for medicinal products.

For in vitro diagnostic medical devices

  • Performance study: a study undertaken to establish or confirm the (analytical or clinical) performance of a device.
  • Test sensitivity: gives the probability of a positive result if the user is actually positive. So, the higher the sensitivity, the lower the chance of a false-negative result.
  • Test specificity: gives the probability of a negative result if the user is actually negative. So, the greater the specificity, the lower the chance of a false-positive result.

Devices in the supply chain

  • Placing on the market: making the device available on the European Union market for the very first time by a manufacturer or importer. Once placed on the market, the device can be transferred to other economic players or directly to users (making available on the market). This action does not apply to devices used in clinical investigations or for a performance study. 
  • Making available on the market: this is the action of "transferring" a device from one economic player to another, or to the user, on the European Union market. This action does not apply to devices used in clinical investigations or for a performance study.  

 Post-market devices

  • Incident: several situations arising from the use of a device may correspond to this word:

    • the device does not work properly;
    • the characteristics or performance of the device are damaged or have deteriorated;
    • there is a use-error due to the ergonomics of the device;
    • there are inadequacies in the information supplied by the manufacturer;
    • any damage as a consequence of a medical decision and action taken or not taken on the basis of information provided by the device;
    • any undesirable side-effect.
  • Serious incident: any incident that directly or indirectly led, might have led or might in the future lead to any of the following:

    • the death of a patient, user or other person;
    • the temporary or permanent serious deterioration of a patient's, user's or other person's state of health;
    • a serious public health threat.
  • Post-market surveillance: all activities carried out by manufacturers, with the help of other economic operators, to create and maintain a routine procedure to collect data on their devices. This enables them to monitor how their devices are being used, and to decide whether preventive or corrective action needs to be taken quickly.

  • Market surveillance: the activities carried out and measures taken by competent authorities to ensure that devices comply with the requirements of the Regulation (e.g. investigation and monitoring of incidents, follow-up of corrective actions in the field) and that they do not endanger health, safety or any other aspect of public interest protection.

  • Materiovigilance: manufacturers of devices made available on the European Union market must notify the competent authorities (for Belgium, the FAMHP) of any of the following:

    • any serious incident concerning their devices made available on the European Union market (unless these undesirable side-effects are already mentioned in the technical documents);
    • any corrective safety measures concerning the device.
    • The FAMHP registers notifications and uses the information reported to carry out market surveillance of the device in question. The resulting actions can take several forms, such as sending the information to hospitals, pharmacists or healthcare professionals, but can also lead to the withdrawal of unsafe devices from the market. The FAMHP also coordinates vigilance and surveillance actions with other competent authorities in the European Union and with the European Commission.
      More information is available on the Materiovigilance page.

  • Serious public health threat: an event which could cause rapid death, serious deterioration in a person's health, or serious illness. This event may also require immediate action, and may result in a large number of illnesses or deaths, or be unusual or unexpected for the given place and time.
  • (Product) recall: any measure aimed at achieving the return of a device that has already been made available to the user.
  • (Product) withdrawal: any measure to prevent a device from being further made available on the market (in the supply chain).
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