In regard to ISO 10993-1, 6.3.2.13 Degradation

Hi. I'm so glad to find this website and to post my first qestion.

I'm supposed to apply for the degradation test for Absorbalbe Suture. In ISO10993-1:2018, I found this part below. (6.3.2.13 Degradation) Would the bold part mean the result of ISO10993-18: Chemical characterization of medical device materials? Since the chemical characterization test is ongoing, we want to skip the degradation test in case there are no toxicities in our product. We are preparing trasfering from MDD to MDR.

Thank you for your help.

6.3.2.13 Degradation
Degradation information shall be provided for any medical devices, medical device components or materials remaining within the tissue, that have the potential for degradation within the human body.

Degradation tests shall be considered if

a) the medical device is designed to be absorbable, or
b) an informed consideration of the finished medical device composition indicates that toxic degradation products might be released during body contact.

Parameters that affect the rate and extent of degradation shall be described and documented.
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In vivo degradation tests might not be necessary if an in vitro/in vivo comparison for the absorbable medical device has been previously demonstrated and in vitro degradation studies show that only the probable products of degradation are present in the predicted quantities, and produced at a rate similar to those that have a history of safe clinical use. When particulate degradation products are generated, tests might not be necessary if they are present in a physical state, i.e. size distribution and shape, similar to those with a history of safe clinical use or sufficient degradation data already exist relevant to the substances and degradation products generated in the intended use already exists.

Welcome to the Cove!

In case you know the mode of absorption of your suture and what degradation products are metabolised in what way, this can serve as an input to a toxicological risk assessment according to ISO 10993-17. In case you can conclude in this assessment that no toxicological limit is exceeded by the nature and quantity of your degradation products during suture absorption, you may be in a position to justify omitting dedicated degradation testing.

Maybe you have already related data / tox. assessments already at hand for the existing MDD absorbable suture, for which requirements related to degradation were technically not significantly different?

HTH,

Thank you for your advice.

We have maintained CE MDD with consignment of wholly manufacturing process to other company. (only starage and sales in my company.)
That's why we don't have our own tox. assessments data yet.(the outsourcing company have just finished tox. assessment, but they said they can't provide us the result due to the problem in our mutual contract.) While we're at the time to trasfering to MDR, we are preparing our own manufacturuing not to consign to other company.

We know the mode of absorption of the suture and what degradation products already, but don't have tox. data and assessment. I think that it's just better to proceed with the degradation test regardless of possibility of omitting degradation test for safety.

I do not want to curb your enthusiasm to opt for degradation testing. However, it may be less tedious to
- either fix the issues in your supplier contract to get the "outsourced" tox data (which, actually, would belong into your technical documentation anyway), and/or
- liaise with e.g. the consulting division of the test house you have in mind for your degradation testing whether they can at least reduce testing by making use of your knowledge of mode of absorption of the suture and formed degradation products

- In terms of renewal of the contract, since the outsourcing company was merged into a large company, they are reluctant to provide further data except those in the current contract.
- I haven't come up with this idea. I think it sounds like we can try to negotiate to make the result suitable for my company with prior knowledge.

You are much more helpful than my supervisor. Thanks for your time out of your busy schedule.