One of the issues surrounding UDI (Unique Device Identification) could be the definition of equipment. By definition, we mean classification of the repairs/state of refurbishment of the equipment prior to sale. Many of the major UDI stakeholders cannot agree on what is refurbished versus remanufactured. We are working to make sure that simple changes do not render equipment as remanufactured.
IAMERS believes that minor changes to equipment should not require a new UDI; and that the original UDI from the OEM should be used unless there are major changes resulting in a change of the intended use of the product. There is speculation that in the absence of agreed upon definitions for used devices, everything – other than As is, where is will be defined as “Remanufactured”.
The final rule regarding UDI has not been published as of now. The current scheduled date for the final rule is June 19, 2013. However, there is speculation that the June date may not be met. After the final rule is published, UDI will be a requirement three (3) years thereafter. Note: the three year period applies to Class II devices as defined by FDA.
The stakeholders in this process include COCIR and MITA (a division of NEMA) in cooperation with IMDRF (International Medical Device Regulators Forum). The IMDRF is the offshoot of the Global Harmonization Task Force (GHTF). IMDRF, different from the GHTF, does not allow trade associations to be members, however, it is clear that they are working with certain trade associations.
For more information about IMDRF please see www.imdrf.org.
We’d like to hear from you on this subject. What do you think?
