AMDR President Dan Vukelich will speak at the MedTech 2018 summit Thursday, June 14th on the European Medical Device Regulation and requirements on the reprocessing of single-use devices. As the foremost expert on international regulation and requirements for single-use device reprocessing and remanufacturing, Mr. Vukelich will be on hand to discuss the latest updates on national implementation of reprocessing single-use devices and implications of Common Specifications for industry.
“AMDR is eager to again meet with representatives from various EU Ministries of Health, the European Commission, Notified Bodies, Competent authorities and other stakeholders to address the important role medical device remanufacturing has in helping hospitals maximize the value of existing medical device assets, in elevating patient safety, and in giving hospitals access the resources to adopt new technologies. By ‘opting in’ to the new EU Medical Device Regulation’s requirements for SUD reprocessing, countries in Europe can stop inappropriate hospital reuse of single -use devices and thereby promote patient safety. But more than that, but moving reprocessing to regulated, commercial remanufacturers in Europe, hospitals will be promoting competition, innovation and environmentalism in addition to cost savings…. and taking control of maximizing the value of their own medical device assets,” said AMDR President Dan Vukelich.
The MedTech 2018 summit will cover 8 crucial areas: EU MDR, IVDR, Post Market Surveillance and Vigilance, Clinical Evaluations and Investigations for Medical Devices, Medical Device Law, Drug Device Combination Products, Regulatory Affairs in Emerging Markets, and Companion Diagnostics.
AMDR is the global trade association consisting of members of the commercial single-use device reprocessing and remanufacturing industry. AMDR represents regulated, commercial reprocessing, promotes reprocessing as an important healthcare strategy that helps hospitals and healthcare providers increase quality, reduce costs and improve patient care, and protects the interests of its members in regulation, legislation and standard-setting world-wide.
AMDR’s mission is to protect the trade interests of the global commercial reprocessing industry and promote reprocessing as a healthcare strategy that increases quality, reduces costs and improves patient care.