European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)
“…Regulation (EU) 2017/745 allows reprocessing of single-use devices only where it is permitted by national law. As regards single-use devices that are reprocessed and used within a health institution, Regulation (EU) 2017/745 allows Member States
Global Reprocess Medical Devices Market: Stryker Sustainability Solutions and Sterilmed, Inc. Emerged as the Leading Players in the Industry
AnalystView Market Insights predicts global reprocessed medical device market to grow at 17.4 percent and reach $5.6 billion by 2025. “The global reprocessed medical devices market is expected to grow at the growth rate of
Commonly Reprocessed Devices, AMDR Overview
https://amdr.org/commonly-reprocessed-medical-devices/
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