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New : Medical Technologies Pact

6 October 2016 - 9:59

Public authorities and industry join forces to greater safety and quality

Maggie De Block, Minister of Social Affairs and Public Health and the medical technology industry, beMedTech, signed a pact to improve the safety and accessibility of medical devices for the patient. In addition, the agreement also encourages investment in innovative medical devices, such as 3D printing and mobile health applications.

The Pact Medical Technologies  comprises five parts: measures applicable to all medical devices, and also specific measures for implants, in vitro diagnostics, consumables and medical equipment.

The pact includes:

  • Adaptation to the new European legislation, developed after the fraud with PIP breast implants in 2010.
  • A system of selfcontrol (to be determined) for the sector.
  • Creation of Belgian medical device database (based on the European database)
  • New rules enabling the use of medical devices for treatment at home
  • Possible (faster) reimbursement for new innovative technologies
  • Creation of a register of the major medical imaging equipment

The pact is available in French and Dutch.

Sources :

  • beMedTech Newsletter :Fr & Nl
  • Press release Cabinet of Maggie De Block : Fr & Nl