Fast and uniform implementation of the new Regulations on medical devices

The Regulations for medical devices are being adapted and, as a result, existing Regulations are being tightened. The consequences of this tightening have not been sufficiently considered so far.

©Daan Stevens

Medical devices make an essential contribution to healthcare for the benefit of all patients. They are fundamental for the diagnosis, treatment, prevention, and monitoring of diseases. Medical devices include all products (instruments, equipment, appliances, software, materials, …) designed by the manufacturer for use on human patients. Their uses include detecting, preventing, monitoring, treating or alleviating diseases and injuries, compensating for disabilities and examining, replacing or modifying anatomical structures or physiological processes.

Our Positions:

  • Speed up and uniformity implement notification processes,
  • publish delegated and implementing acts as soon as possible and
  • and specify new and amended legal requirements as soon as possible.

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Fast and uniform implementation of the new Regulations on medical devices and on in vitro diagnostic medical devices!