Responsible Retirement: Navigating U.S. Regulations for European and Global Medical Device Disposal
Compliant Disposal for Global Medical Device Manufacturers
IoMT Recycling Solutions provides fully compliant, end-to-end disposal services specifically designed for medical device manufacturers worldwide. Our processes adhere to the European Union’s Waste Electrical and Electronic Equipment (WEEE) Directive, ensuring environmentally responsible disposal of electronic devices, and comply with ISO 13485 standards, maintaining rigorous documentation for risk management, traceability, and regulatory compliance.
In addition, IoMT maintains various certifications including ISO 9001:2015 (quality management), ISO 14001:2015 (environmental management), and ISO 45001:2018 (occupational health and safety). Within the United States, we are R2-certified as a responsible electronics recycler, a New Jersey Class D licensed electronic recycling facility, and a registered U.S. EPA universal waste electronics processing facility.
With IoMT, international manufacturers can confidently ensure that their medical devices are retired in full compliance with the highest environmental, regulatory, and data protection standards.
Case Study: Retiring a National Medical Device Network
A leading international medical device manufacturer partnered with IoMT to manage the retirement of thousands of ultrasound systems deployed across hospitals in the United States. The manufacturer supplied a comprehensive list of locations and a removal schedule aligned with its multi-year equipment upgrade program.
For this project, IoMT coordinated directly with each healthcare facility, arranging pickup logistics and providing the manufacturer with detailed reports including device types, quantities, and serial numbers recovered. All devices were transported to IoMT’s secure processing facility for disassembly and recycling. Upon completion, IoMT issued certificates of destruction that satisfied both regulatory requirements and the manufacturer’s environmental and data privacy standards. These certificates were archived in IoMT’s secure cloud-based document library for convenient online access and retrieval.
The Benefits of a U.S. Based Medical Device Recycler
At first, European-based manufacturers may consider working with a disposal provider in their own region. However, once their devices enter the U.S., the regulatory environment changes dramatically, coupled with FDA oversight and strict data privacy laws.
For international medical device manufacturers, attempting to manage these obligations independently is costly and complicated. IoMT eliminates that burden by acting as a U.S.-based compliance expert.
IoMT offers international medical device manufacturers several benefits, including:
- Consultation on federal, state, and FDA requirements
- Complete tracking and reporting
- Nationwide service reach, capable of handling both small and large disposal projects
Conclusion
For international medical device manufacturers, choosing a U.S. based disposal partner is a compliance best practice. With years of experience in our industry, IoMT Recycling Solutions is a proven leader in regulatory processes and recycling compliance, ensuring the responsible retirement of medical devices in the U.S. market. Our team partners with international manufacturers to meet their obligations with confidence.
Want more information on IoMT’s expertise in partnering with international manufacturers? Contact us today!