European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
Single-Use Devices and their Reprocessing “…The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation. The reprocessor
OR Today Features AMDR’s Dan Vukelich
SUD Reprocessing was featured during yesterday’s OR Today Webinar Series for continuing education credits. “SUD Reprocessing: Financial & Environmental Impacts for the OR” is archived on the OR Today Website, and was presented by Dan
European Union Adopts final Medical Device Regulation: AMDR urges European Member States to “opt in” to CE marking paradigm for SUD reprocessing
Last week marks a milestone for medical device makers, including commercial SUD reprocessors in Europe. After nearly five years of negotiations, the European Union finally passed a comprehensive new EU wide Medical Device Regulation (MDR).
AMDR Position on the European Council’s Partial General Approach to a Proposed Medical Device Regulation
Proposal for a Regulation of the European Parliament and of the Council of the on Medical Devices and Amending Directive 2001/83/EC On behalf of its member companies, the Association of Medical Device Reprocessors (AMDR),
ReMaTec News Turns Spotlight on Reprocessing
ReMaTec News taps into the world of “single-use” device (SUD) reprocessing and in doing so brings news from the FDA-regulated industry of third-party medical device reprocessing to its global readership. The Magazine, which focuses on