Association of Medical Device Reprocessors
Budget
€100 — €0
EP Access
0
accredited persons
Staff
2
0.2 FTE
EU Grants
None
Mission & Goals
The Association of Medical Device Reprocessors (AMDR) is the global trade association representing professional, regulated medical device reprocessing and remanufacturing companies. AMDR, founded in 1999, has operational bases in Washington, DC and Berlin, Germany. Its members are based in the United States and Germany, and AMDR works to harmonize international regulation of single use device (SUD) reprocessing as a manufacturing activity, subject to medical device manufacturer requirements.
EU Legislative Interests
Pursuant to the European Union's Medical Device Regulation (MDR), AMDR seeks a harmonized regulatory framework for single-use device (SUD) reprocessing and remanufacturing. AMDR works to remove the existing EU Member State Opt in as it exists in Article 17.1 of the EU MDR as it is anticompetitive, runs afound of the single market and free movement of goods, and bad public policy. In the meantime, AMDR also encourage EU Member State to opt in to Article 17's reprocessing regulation, thereby allowing regulated, safe, reprocessed and remanufactured medical devices as a means to promote the circular economy, reduce cost, waste and build supply chain resiliency. AMDR will also focus on amending Article 17.6 and 17.9 of the EU MDR as we see it as a needless obstacle to embracing circularity in healthcare.
Communication Activities
AMDR publishes a quarterly newsletter to subscribers and is available on its website. We also publish a bi-annual "research digest" to summarize all research at the intersection of health and sustainability and of potential interest to academics, policy-makers and clinicians.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
AMDR is a member of: the standard setting organization, the Association for the Advancement of Medical Instrumentation:https://www.aami.org/; the Remanufacturing Association Alliance: http://www.remancouncil.org/collaborate/partnerships/remanufacturing-association-alliance; and
Organisation Members
http://amdr.org/about-amdr/members-2/ Members are: Sustainable Technologies, a Cardinal Health business Innovative Health Medline ReNewal ReNu Medical, a subsidiary of Arjo, Inc. Stryker Sustainability Solutions Vanguard AG Vein360
Commissioner Meetings
No recorded meetings with EU commissioners.