The International Medical Device Regulators Forum (IMDRF) posted four new final documents on unique device identification (UDI) and labeling principles, and four revised documents on IMDRF’s standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.
Of the four new documents, three are on UDI. These include one technical document—the UDI system application guide—and two information documents on the system requirements relating to UDI use in health care and the use of UDI data elements across IMDRF jurisdictions.
The 68-page UDI application guide operationalizes a 2013 UDI guidance in which IMDRF set forth a high-level conceptual framework for UDIs. “Regulatory authorities are responsible for developing the UDI [database] in their jurisdiction based upon local policy requirements and the principles developed in the IMDRF UDI guidance and this document,” the document says.
The UDI application guide provides a set of recommendations for developing regional UDI databases (UDID), identifies roles and responsibilities and list considerations for UDI implementation. Yet it recognizes additional guidance may be needed in the future. “As the UDI system matures, it will require ongoing process and data improvements driven by multi-stakeholder efforts to meet both submitter and user requirements,” IMDRF says.
Another new 28-page technical document harmonizes the principles for labeling medical devices and in vitro diagnostic (IVD) devices, including the content of the label and instructions for use. The final document also offers labeling principles on devices containing software or software as a medical device, devices intended for laypersons and for information intended for a patient…