ODEP ASSURE
From time to time, manufacturers approach ODEP to say that they would like to make a modification to an implant but that they do not want it to lose its ODEP rating.
ODEP takes any modification very seriously. Historically, some so called “Minor Modifications” have led to disasters, but ODEP realise that making improvements should not be frustrated.
Thus, when a manufacturer wants to modify a product and keep its ODEP rating they should notify ODEP. The modification will then be very carefully assessed by members of the panel and a decision will be made as to whether the modification can be accepted under the present benchmark or not.
Only, if the panel decide that the modification is not going to significantly alter the performance of the device, will ODEP ASSURE be offered. Where ODEP feel that there is any significant risk with this modification, this offer will not be made.
Reference Products and their Modified Variants are listed separately on the ODEP website. To make it clear to surgeons, procurement managers and other users of ODEP, details of the Modified Variant, as seen on the ODEP website, are posted next to the “parent implant” with its ODEP rating.
ODEP wish to remind any manufacturer looking to modify one of their products, whilst retaining its ODEP rating, they should contact ODEP on ODEP@necsws.com. ODEP are always pleased to discuss any question or issue that a manufacturer or another interested party wish to make.
