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SUBMISSIONS


FAQ

1.     Which products does ODEP provide ratings for?

2.     Why do my products need an ODEP rating?

3.     What do the different ratings mean?

4.     Is 10A* the best?

5.     How do I get an ODEP rating for my product?

6.     How quickly will ODEP provide a rating following my submission?

7.     What data do I need to provide to ODEP?

8.     Can I use non-NJR data?

9.     Can I get an ODEP Rating for a new product?

10.   Can I request an ODEP rating for products not on sale in the UK?

11.   What if I don’t get the rating I want, can I appeal?

12.   How often do I need to update my products ODEP rating?

13.   What if I modify  / change my product, does this affect my ODEP Rating?

14.   Can I quote my product’s ODEP Rating in marketing literature?

15.   How do I get more information?

 

1.       Which products does ODEP provide ratings for?

ODEP provides on-going assessment of hip implants to benchmark both hip femoral stems and hip acetabular cups against NICE guidance, providing a rating for implant survivorship and data submission quality. In 2014, the process was extended to include Total knee prostheses. ODEP is currently developing a rating for reverse shoulders to be launched in 2017.
  

 

2.       Why do my products need an ODEP rating?

There is no legal requirement for an orthopaedic implant to have an ODEP rating.  However, regulatory bodies, purchasing authorities and implanting surgeons are increasingly looking for independent assessment of the evidence of long-term outcomes and survivorship associated with implants.  The National Institute of Healthcare and Clinical Excellence (NICE) set a benchmark standard for hips, against which ODEP provide such an assessment of compliance, based upon data provided by the implant supplier.  It is therefore increasingly common that buyers and surgeons use ODEP Rating as a criteria in product selection for hip implants.

3.       What do the different ratings mean?

The ODEP Rating consists of a NUMBER, a LETTER, and a STAR (optional)


The number (3,5,7,10) refers to the number of years for which follow up data is presented.  Thus a 10 rated product has been assessed based upon the presentation of ten or more years of follow-up data. 


The letter (A or B) refers to strength of evidence presented by the manufacturer in support of their product rating. 

  • A – Strong evidence 
  • B  - Reasonable evidence 


The star has been added to the rating system following revised guidelines from NICE in February 2014, in which a benchmark replacement rate of less than 1 in 20 (5%) at 10 years was defined.

 

In addition to these ratings, ODEP also issues ‘Pre-Entry’ Rating status for products that are yet to meet the three year entry benchmark, showing products currently undergoing clinical evaluation.

 

For more detailed information regarding ODEP ratings, please see "How do ODEP Ratings work?"


4.       Is 10A* the best?

Not necessarily.  10A* rated products have the strongest evidence of the long-term performance and outcomes of the product.  Non-10A* rated products have weaker evidence-base, or have less years of data against which to assess performance (but may be showing superior performance to some 10A* rated products).

 

5.       How do I get an ODEP rating for my product? 

You can make a submission online.  Download and complete an ODEP submission form, following the guidelines on the ODEP website.  Following completion, you can upload the form through the ODEP website.  You will receive an acknowledgment of your submission within two working day of submission.  If you have not received acknowledgement in this time period, use Contact Us


ODEP meetings are held quarterly  - for hips in spring and autumn, for knees in winter and summer, with regular meetings to discuss and review improvements to the process scheduled throughout the year. For shoulders, the first meeting will take place in April 2017.  Meeting dates will be posted on the ODEP website, along with closing dates for submissions. Check the ODEP Calendar.


Submissions will be reviewed in the meeting, and you will be notified of the outcome.

 

6.       How quickly will ODEP provide a rating following my submission?

Submissions for each joint will be reviewed bi-annually (hips in spring and autumn, and knees in winter and summer). You will be notified of the outcome shortly after the meeting. If you have not received feedback use Contact Us.

 

7.       What data do I need to provide to ODEP?

You will need to download and complete an ODEP submission form.  You need to complete the form based upon clinical study data collected for the product.  This may include data from RCT, comparative study, unselected consecutive study, selected cohort, and / or national registry data.  You do not need to submit the associated data, just the completed ODEP submission form.


8.       Can I use non-NJR data? 

Yes. Whilst many ODEP submissions are based upon NJR data, submissions are not limited to the use of NJR data.

 

9.       Can I get an ODEP Rating for a new product? 

Yes. New products can apply for a ‘Pre-entry’ status.  You may also wish to consider the Beyond Compliance Service, which is specifically focused upon new product introduction leading to a 3A rating.

 

10.     Can I apply for an ODEP rating for products not on sale (or not intended for sale) in the UK? 

Yes.  Complete the ODEP Submission form in the usual way.

 

11.     What if I don’t get the rating I want, can I appeal? 

Yes.  If your application is rejected, or you disagree with the product rating awarded, you have the right to appeal. 

 

12.      How often do I need to update my products’ ODEP rating? 

ODEP expects products to progress through the 3, 5, 7, 10 year ratings with submissions received at each progression point (plus one year).  Failure to keep ODEP updated of product performance in a timely manner may result in the removal of ODEP rating.  You will be notified prior to removal of a product ODEP rating. 

 

13.     What if I modify  / change my product, does this affect my ODEP Rating? 

Yes.  You must notify ODEP of modifications or changes to the product or its production process, as any such changes may impact the product ODEP rating, and may require additional submissions.  Failure to notify ODEP of any such changes may result in the removal of the product ODEP rating.

 

14.     Can I quote my product’s ODEP Rating in marketing literature? 

Yes.  You may quote a product ODEP rating, as listed on the ODEP website, in marketing literature relating to the product.  Use of the ODEP logo and ODEP rating icon images is restricted to premium listed products only.  For premium product listings contact listings@odep.org.uk

 

15.     How do I get more information? 

Contact Us

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