Meeting ISO 10993-1 2009 Material Risk Assessment Requirements

Ronen E

Problem Solver
Staff member
Moderator
#11
Thanks Ronen,

Just wanted to check here, if we review our contract vendor spec for PU (used in our sub-parts), would that suffice? Or, being the medical device manufacturer ( we do the final assembly at our unit), do we need to perform the biocompatibility tests nevertheless?

Also, if I understand right, if the vendor specs are of medical grade PU with the applicable biocompatibility tests performed, we as the manufacturer, need not submit the device for the tests?

Thanking once again, for your guidance.
Hi,

Your questions lack regultory (or other) context. Since you posted in a thread whose title includes "ISO 10993-1 2009", I'll answer from the narrow perspective of compliance with that standard.

The standard generally requires that biological evaluation is performed at the finished (assembled) medical device level. On the other hand "biological evaluation" by that standard doesn't have to include testing, and when it does the standard doesn't rigidly dictate what tests are required. It's a matter of careful assessment by qualified and competent specialists (eg 3rd party test labs' expert toxicologists). That assessment should take into account all relevant available information, including your device's nature and intended use, the components' manufacturers stated intentions (how their parts are to be used), what your assembly processes involve and how they affect the purchased components, any available biocompatibility test reports and certificates at the component (as-made) and raw material level, etc. etc.

Going on practically nothing here, I'll take a wild guess that whatever information you already have or can collect from your vendors may help reduce the amount of actual testing you'll have to run, but not to 0.

Other than that I can't really responsibly say much.

Good luck,
Ronen.
 
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D

Dtbal

#12
Hi Ronen,

I posted the query based on limited information I have been provided with as well. We are in our development phase and just stepping into a small pilot run.
This is fairly new to us.
We really appreciate your insight given the limited information.

Thanking once again!

Cheers!
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Hi Ronen,

I posted the query based on limited information I have been provided with as well. We are in our development phase and just stepping into a small pilot run.
This is fairly new to us.
We really appreciate your insight given the limited information.

Thanking once again!

Cheers!
That’s cool. If you need someone to walk you through the regulatory path, you know where to find me...
In general, it’s good to get your regulatory strategy sorted well before going into production. It can save a lot of money and time in some cases.

Cheers,
Ronen.
 
S

shiggins63

#14
That’s cool. If you need someone to walk you through the regulatory path, you know where to find me...
In general, it’s good to get your regulatory strategy sorted well before going into production. It can save a lot of money and time in some cases.

Cheers,
Ronen.
Do you have a template or an example of this type of assessment that you could share?
 
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