EU Sets Common Specifications for Reprocessing Single-Use Devices
The European Commission has established common specifications for reprocessing single-use devices under the EU Medical Device Regulation.
Under the new regulations, single-use devices may be reprocessed, and EU member states may apply their own rules to reprocessed devices within their own jurisdictions as long as the rules comply with the common EU specifications.
Reprocessing includes sterilization, testing, packaging and labeling, among other steps. The new requirements call for more detailed validations before reprocessed devices are released.