Disclaimer

Important: The data on the submission form incorporates data supplied by third parties. It is carefully considered in good faith, and a rating is granted by a panel of experienced orthopaedic surgeons. The ODEP rating is not designed to form part of the standard regulatory approval process. Beyond Compliance, ODEP, NEC Software Solutions (UK) Ltd, SCCL (Supply Chain Coordination Limited) and the surgeons involved do not accept liability for any errors or omissions which could affect the final ODEP rating.

Submissions to ODEP can only be made using the appropriate pro-forma, which are accompanied by explicit guidelines for completion. It is recommended that all interested parties review these guidelines and submission templates for each product type in order to understand precisely what is expected from manufacturers and suppliers.

ODEP expects companies to apply for ratings that match the mean follow-up data for the cohort group. It is also expected that implants progress through the ODEP benchmark timelines at 3, 5, 7, 10, 13 and 15 years. Failure to progress will be queried by ODEP and could result in the loss of an ODEP rating.

To allow for access to registry data, companies may apply for a 12-month extension to the benchmark timeline in order to allow sufficient time to obtain the necessary data.

Please note that ratings awarded to products during the Submissions Review meeting are communicated to companies shortly after the meeting, but are only published on the ODEP website following the conclusion of any subsequent appeal hearing (held usually within six weeks of the date of the meeting).

Before Completing a Submission

Please note the following carefully:

• Only one clinical series should be presented per pro-forma submission. The series may be single-centre or multicentre. Repeated reports on a single series — for example, publication of the same patient population in different journals — must be clearly identified.
• Spreadsheet cells may be enlarged by increasing the row width.
• Do not merge cells or add new headings.
• Fill in all fields.
• Where necessary, use the abbreviation NR (not reported) if a response is missing or undetermined, or NA (not applicable) if a response is not required.
• ODEP requires a photograph of the product to be included within the submission form.

Manufacturers are advised to ensure that clinical data included within their submission is as current as reasonably practicable. The panel considers data no older than two years at the point of submission to be appropriate in most circumstances. Where older data is presented, manufacturers should provide a clear rationale, and the panel may request supplementary or updated evidence at its discretion.

If assistance is required when completing the submission form, please contact ODEP directly.

Subscribers to the NJR supplier feedback system are entitled to assistance from NEC Software Solutions (UK) Ltd with the completion of ODEP submissions, but only in respect of NJR data.

Images must clearly show the actual implant components to help surgeons and patients identify products on the ODEP website.

Mandatory Requirements

1. Authenticity

• Images must be photographs of real, physical implants
• Computer-generated renders, CAD images, or AI-generated images are not acceptable
• Even high-quality renders that appear photographic will be rejected

2. Technical Specifications

• File format: .jpg or .png
• Recommended size: 800 x 800 pixels minimum
• Background: Plain white or neutral

3. Content Requirements

• All components of the rated construct must be clearly visible
• Components should be shown in an “exploded” view (separated) or assembled — whichever best shows individual parts
• Image must be in focus with adequate lighting
• No excessive photographic effects or filters that obscure implant details

How to Demonstrate Authenticity

Acceptable photographs typically show:

• Natural reflections and shadows consistent with physical objects
• Camera or photographer reflections in polished surfaces (often visible in metallic components)
• Realistic lighting and depth
• Minor imperfections typical of physical photography

Examples of Unacceptable Images

• Computer renders, even photorealistic ones
• Images with artificial or CGI reflections or backgrounds
• Overly processed images where implant details are unclear
• Images showing only partial components
• Low resolution or blurry images

Note on Peripheral Components

Peripheral screws need not be photographed unless they are integral to the construct rating. Please refer to your provisional rating feedback for specific requirements.