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Belgium

Regulatory Agency

The Federal Agency for Medicines and Health Products (FAMHP) regulates the medical devices in Belgium

Medical Device Definition

Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • the investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state,
  • 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.

System: means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.

Procedure Pack: means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Medical Device Classification System

Classification Risk Level Examples
l
Is (sterile)
Im (measuring)
Ir (reusable)
 Low Risk Wheelchairs, stethoscopes, Spectacles
IIa Medium Risk Dental fillings, Surgical Clams, Tracheotomy tubes
IIb Medium High Risk Lung ventilators, Bone fixation plate, Condoms
III High Risk Pacemakers, Heart valves, Implanted cerebral, simulators

Regulatory Approval Process

Classification

Approval Procedure

I
  1. Manufacturers from outside the European Union with a Belgian authorized representative to register their device(s) in Eudamed
  2. Manufacturers of Class I devices can register themself with Eudamed in the “Actors” module.
  3. This registration is currently voluntary. The legal obligation to register in Eudamed will start 6 months after the date of the functionality declaration of this module in the Official Journal of the EU.
  4. This means that the registration in Eudamed will also be considered as a registration in the web portal.
  5. Manufacturers and authorised representatives who do not yet use Eudamed must, inform the FAMHP before placing their class I medical devices on the market.
  6. The notification must be made via the “marketing notification” form.
  7. The various documents can be sent electronically by e-mail to notifications.meddev@fagg-afmps.be. If multiple notifications are made at the same time, please group the documents by notification.

IIa
IIb
III
    1. In order to affix the CE marking to a class IIa, IIb or III medical device and to place it on the market, the manufacturer must contact a notified body.
    2. This will provide it with a CE certificate after a conformity assessment.
    3. The FAMHP has developed a web portal (https://www.vas.ehealth.fgov.be/portal/nl/) for the registration of market participants carrying out an activity related to medical devices.
    4. There is no separate requirement to register a device in Belgium.

Additional Information

Approval Timeline

Not specified by the agency

License validity period

5 years

Fees

Not specified by the agency
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