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EU Commission Release Report from Study Conducted Regarding the Implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

The EU Commission has released a report from a study that they have conducted concerning the reprocessing and reuse of single-use-devices in the EU. The study aimed to evaluate how the provisions that have been established in Article 17 of the MDR, which regulates the reprocessing of Single Use Devices (SUD’s), have been implemented and how they function in practice. In this study, the current market situation for the reprocessing and reuse of SUD’s was surveyed and analysed across the 27 EU member states and Iceland, Liechtenstein and Norway.

The report presents and overview of the following:

  • The national decisions regarding the reprocessing of SUD’s, certification processes for SUD’s by notified bodies.
  • Reprocessing of SUD’s by manufacturers and health institutions
  • Reuse of purchased reprocessed SUD’s by health institutions.
  • Challenges and opportunities of stakeholders
  • Actions recommended by stakeholders.

The report on the study can be accessed using the following link