Biological Evaluation requirements per ISO 10993 - Medical Device Testing

[jbdominguez]

Can I get some assistance? New issue that has come before me (most are new to me).

We are coming out with a product we intend to market that is a Class I Exempt medical device that is virtually identical to a product that is currently commercially available. We have reviewed ISO 10993-1:2009 and come to the conclusion that we do not need to perform a biological evaluation. We have come to this conclusion by examining Figure B.1 of Annex B in ISO 10993-1:2009 by determining that the material is the same as in an existing commercially available device and that the device has the same manufacturing, body contact and sterilization properties. The product contains a hydrogel sheet, a foam sheet with adhesive backing, and adhesive tape. Biological testing has been performed on the adhesive backing of the foam and the adhesive sheet by their respective manufacturers.

In your opinion, are we correct in determining that a biological evaluation does not need to be performed? If so, how do we show this to customers who are requesting test results?

Thanks!!

 

[MIREGMGR]

Re: Need Medical Device Testing?

We have reviewed ISO 10993-1:2009 and come to the conclusion that we do not need to perform a biological evaluation. We have come to this conclusion by examining Figure B.1 of Annex B in ISO 10993-1:2009 by determining that the material is the same as in an existing commercially available device and that the device has the same manufacturing, body contact and sterilization properties. (...) In your opinion, are we correct in determining that a biological evaluation does not need to be performed?

Implicit in the ISO 10993 decision process is that the "material is the same" statement is objectively provable (i.e. same material type, same detailed formulation particularly including secondary constituents, processing contaminants/byproducts. colorants, etc., generally same vendor/formulator/grade description), you are in possession of the prior-product biocompatibility data for the "same" material, and that data does in fact demonstrate biocompatibility.

You would not be able to market without your own biocompatibility testing if the material is the "same" only in regard to its top-level descriptor (i.e. their product is made of polycarbonate, our product is made of polycarbonate), or if some aspect of their testing is inapplicable to your product, or if the manufacturer has told you the material is biocompatible but you don't have the data.

If so, how do we show this to customers who are requesting test results?

The same as if you had conducted the testing...you will have applicable data in your tech file, whatever path applied to the sourcing of that data.

 

[Eggsn]

Re: Need Medical Device Testing?

From what I know about hydrogels, each manufacturers do their own formulation and it's very difficult to prove they are the same unless they came from the same supplier. Biocompatibility matters not only through each component level but also through looking at the device as a whole (i.e. manufactured finished product).

If you still come to the conclusion that you do not need testing, then ensure that this is filed and written up to show your auditors or your customers. The written justification should come with technical specs demonstrating similarity, etc. and coming/signed off by a qualified person.

Since your pads are most likely for skin use, biocompatibility testing isn't really that difficult to get. It's just a matter of time, money, and a few samples. It is sometimes easier to put these types of things to bed specially if you're dealing with many customers asking for them. If you do decide to test, I strongly suggest to test the hydrogel separately if you plan on doing certain testing like for cytotoxicity as hydrogels tend to interfere with the test methods normally used and cause a false negative result.

Hope that helps.