Ban on reuse

The Ministry of Health proposes a complete ban on the reprocessing and reuse of medical devices intended for single use. The motives are the serious risks to public health, including infections and intoxication from residual chemicals.

There is no indisputable evidence for the cost-effectiveness of the reprocessing procedure, given the logistical and insurance costs.

Health technology assessment

The draft introduces a health technology assessment for medical devices, similar to that for medicines. The goal is to achieve greater cost-effectiveness in the use of public funds.

Restrictions for traders

  • Wholesalers of medical devices will no longer be able to hold retail licenses for medicinal products (pharmacies).
  • A 6-month grace period is provided for bringing operations into compliance with the new requirements.

Sanctions for specialists

Doctors and medical professionals who fail to report an incident with a medical device face fines ranging from 511 to 2045 euros for a repeat offense.