ODEP Assure is a service providing a mechanism for an ODEP-rated implant to be modified but still maintain its present rating.

A manufacturer submits details of the modification to the ODEP Panel who determine if it is sufficiently minor to not warrant a loss of the implant’s current rating. Where such approval is given the modified variant is analysed separately to the unmodified implant to ensure the performance of the two remain consistent.

If the Panel determines the modification is a significant change it will reject the submission and the manufacturer then has the option to have the implant’s present rating removed and re-start the ODEP process, or have the modified variant excluded from the rating.

The duration of ODEP Assure monitoring required for any one implant may vary based upon the consideration of the Panel on a case-by-case basis. It is likely to be a three-year monitoring arrangement in most cases, but the performance of the modified implant will be the deciding factor.

The implant’s details on the ODEP website will be amended to include a statement that it has been subject to a modification and that it is in the ODEP Assure process, with associated dates.

For a more detailed explanation of the service and how you can make an application to ODEP Assure please click here.