To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set out basic UDI requirements, including recommended “shared” data elements, in their guidance document Unique Device Identification ( ) of Medical Devices. However, as regulators, purchasers, and other global stakeholders begin to develop and implement UDI (or UDI-like) systems, they are also trying to address device identification initiatives and support national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement).
These new use cases create challenges for device manufacturers who must establish and maintain robust systems and processes that allow them to submit to various systems and stakeholders the ever-growing (and ever-changing) product information.
This discussion will include:
- Changes in regulatory, commercial, and patient-safety information requirements
- Ways in which device manufacturers can address these growing needs
- How to think locally, nationally, and globally to minimize compliance burdens
About the Presenters:
Jay Crowley, Vice President of Unique Device Identification Solutions, USDM Life Sciences
Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.
Lionel Tussau, Director, Strategic Industries, atrify
Lionel Tussau is leading healthcare initiatives at the product content solution provider atrify, both for connections with Regulatory UDI databases (such as EUDAMED) and GDSN projects between manufacturers, wholesalers, GPOs, and hospitals. He also represents atrify in MedTech Europe, as chairman of the EUDAMED IT Expert group, and is an observer in the EUDAMED MDCG working group. Before joining atrify more than ten years ago, Lionel spent 16 years in the FMCG industry, managing collaborative supply chain projects and implementation of GS1 standards.