- In February 2023, Northeast Scientific Inc., a U.S.-based reprocessor, received FDA 510(k) clearance to reprocess the Philips IVUS Eagle Eye Platinum RX digital catheter. This makes it the first FDA-approved reprocessed digital intravascular ultrasound catheter, enabling significant cost savings for cath labs without compromising clinical performance
- In June 2022, the Association of Medical Device Reprocessors (AMDR) published its “Global Regulatory Standards for Single‑Use Medical Device Reprocessing and Remanufacturing.” This comprehensive roadmap harmonizes international regulations and empowers regulatory bodies in over 19 countries to safely integrate reprocessing into healthcare systems
- On January 1, 2025, Denmark enacted an amended Executive Order that formally allows the reprocessing and reuse of single-use medical devices under MDR Article 17. This regulation mandates CE-marking by the reprocessor and positions Denmark among early adopters promoting sustainable reprocessing practices
- In November 2024, the European Commission delivered its first report on the implementation of MDR Article 17 across EU Member States. This evaluation highlights how various countries are adopting secure, compliant frameworks for single-use device reprocessing under national law
