AMDR comments on issues of EU single-use medical devices specifications
The Association of Medical Device Reprocessors urged the European Commission to delete provisions of Article 5 of its specifications for reprocessing single-use medical devices because of a lack of legal basis for placing obligations on
European Commission’s Proposed Common Specifications for Hospital Reprocessing of Single Use Devices
AMDR Response to Stakeholder Comments The European Union is moving closer to fully implementing its requirements for single-use device (SUD) reprocessing and remanufacturing as part of the new comprehensive European Medical Device Regulation. On August
EU Action Needed to Reduce Costs and Environmental Impact of Healthcare
On Tuesday, 20 August 2019 the European Commission closed its feedback period on safety and performance requirements for single-use device reprocessing. As the 26 May 2020 deadline for compliance with the new European Medical Device
Wikipedia:
Single Use Medical Device Reprocessing “Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its
‘EU Action Needed to Reduce Costs and Environmental Impact of Healthcare’
On Tuesday, 20 August 2019 the European Commission closed its feedback period on safety and performance requirements for single-use device reprocessing. As the 26 May 2020 deadline for compliance with the new European Medical Device
Innovative Health and Northeast Scientific Partner to Increase Cost Savings in Healthcare
Innovative Health, a single-use cardiology medical device reprocessing company, has announced it has engaged in a formal joint venture with Connecticut-based reprocessor Northeast Scientific. The joint venture aims at enhancing the impact on device cost