Strapline headder

0845 345 9991  enquiries@odep.org.uk

Text/HTML

Submit a Product

Text/HTML


Submission Guidelines

Disclaimer
IMPORTANT:

  The data on the submission form incorporates the data supplied by third parties. It is carefully considered in good faith, and rating is granted by a Panel of experienced orthopaedic surgeons. ODEP rating is not designed to be 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. 
These are accompanied by explicit guidelines for completion. It is recommended that all interested parties view these guidelines and submission templates for each type of product so as to see exactly what is  expected from manufacturers / suppliers.

ODEP expect 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 loss of an ODEP rating.  

To allow for access to Registry data, companies can apply for a 12 month extension to the benchmark timeline to allow sufficient time to obtain the necessary data.

Please note that the ratings awarded to products during the Submissions Review meeting are communicated to companies shortly after the meeting, but only published on the ODEP website after the conclusion of any subsequent Appeal hearing (held usually within 6 weeks from the date of the meeting).

Before completing a submission please note carefully
Only one clinical series should be presented per pro-forma submission. The series may be single or multicentre. Repeated reports on a single series (e.g. 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 abbreviation NR (not reported) if the response is missing or undetermined or NA (not applicable) if the response is not required.
ODEP expect a photograph of the product added to the form

If persons completing the submission form require help please contact ODEP.

Subscribers to the NJR supplier feedback system are entitled to help to complete ODEP submissions from NEC Software Solutions (UK) Ltd but only for NJR data.

 

 

BC Section Menu Left

Menu

companies logos