As part of its continued push to foster global regulatory convergence, the International Medical Device Regulators Forum (IMDRF) has opened three new consultations on labeling, unique device identifiers (UDIs) and adverse event reporting.
The 31-page proposed document
, released 12 July by the IMDRF Good Regulatory Review Practices group, aims to provide globally harmonized labeling principles (content and format) for medical devices and IVDs and to support the IMDRF Essential Principles of Safety and Performance.
The document specifies the general labeling principles, including specific sections on the label, instructions for use and information intended for the patient. The guidance also features sections on labeling principles for software as a medical device and such principles for devices and in vitro diagnostics (IVDs) intended only for layperson use.
This consultation will close on 12 September 2018.
The 60-page proposed guidance
, released by the UDI Working Group on 12 July, provides a framework for regulatory authorities that intend to develop their UDI systems in a globally harmonized approach.
The guidance features sections on the fundamental elements of a harmonized USI system, the guiding principles for designing and operating such a system, and the content, structure and representation of a UDI.
The guidance also discusses the application of a UDI to packaging, UDI databases and establishing responsibility for creating and maintaining a UDI system.
“The benefit and purpose of a UDI system will only be realized if healthcare stakeholders integrate and obtain value in their systems from UDIs and data in associated Unique Device Identification Databases (UDIDs),” IMDRF writes.
The working group also released two additional information documents on UDIs. The consultation on the proposed guidance will close on 12 October 2018.
Adverse Event Reporting
Prepared by the Adverse Event Working Group, this 24-page consultation
features a harmonized terminology for reporting adverse events related to medical devices, including IVDs.
“Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory authorities,” IMDRF said.
This consultation will close on 12 October 2018.