Challenges in Reprocessing Single-Use Devices Under EU MDR

The ‘Report on the Operation of Article 17 of Regulation (EU) 2017/745 on Single-Use Devices and Their Reprocessing’ was adopted in November 2024, this report providing data on the implementation of Article 17 of the MDR.

This includes the EU countries plus Iceland, Liechtenstein, and Norway. The MDR introduced specific rules on single-use devices (SUD) and their reprocessing. Reprocessing may only take place where national law permits. Currently, this includes 10 countries, while 20 countries do not allow reprocessing of SUDs.

A study was contracted by the Commission to collect data as input to this report. The information will be used as proposals to amend Article 17 of the MDR, as part of the targeted evaluation of the MDR.

Challenges and Conclusions:

• • Notified Bodies Scarcity: There are very few Notified Bodies offering certification services for the reprocessing of single-use devices (SUDs). Securing a Notified Body for this purpose remains challenging.
  • Specialized Expertise Required: Reprocessing SUDs requires specialized expertise and resources. Uncertainties about requirements, Notified Bodies availability, and SUD suitability deter investment in reprocessing.
  • Health Risks: Concerns about health risks further complicate reprocessing efforts.

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