Regulatory Open Forum

Dear Anon,

This is mainly dependent on your device type and the extent of manufacturing changes.

Check out ISO 10993-1:2018 Annex B Section B.4.5.1 Changes which can require re-evaluation of biological safety.

If your devices are low risk in respect to biocomp. and the changes do not affect biological aspects (e.g. you transfer all manufacturing equipment as well, use the same operating supplies etc.) then a well documented assessment could work out.

If the changes might introduce any additional biological risk, e.g. you use new machines that might result in other or higher production residues, use new operating supplies, other cleaning agents for your tools etc.,  you should create objective evidence via testing that your devices are still biologically safe.

Over the past couple of years I have worked in several of such transfer projects. Biological equivalence via chemical characterization of extractables/leachables worked out always great for my products (usually medium risk devices from a biological perspective).

ISO 10993-18:2020 Annex C gives guidance on biological equivalence. Big benefit: No animals needed and you learn how good or bad your products are from a chemical perspective. Section 5 of ISO 10993-18:2020 explicitly points out that chemical characterization can be used for manufacturing process and site changes. 

Kind regards,
Michael

Dear Anon,

This is mainly dependent on your device type and the extent of manufacturing changes.

Check out ISO 10993-1:2018 Annex B Section B.4.5.1 Changes which can require re-evaluation of biological safety.

If your devices are low risk in respect to biocomp. and the changes do not affect biological aspects (e.g. you transfer all manufacturing equipment as well, use the same operating supplies etc.) then a well documented assessment could work out.

If the changes might introduce any additional biological risk, e.g. you use new machines that might result in other or higher production residues, use new operating supplies, other cleaning agents for your tools etc.,  you should create objective evidence via testing that your devices are still biologically safe.

Over the past couple of years I have worked in several of such transfer projects. Biological equivalence via chemical characterization of extractables/leachables worked out always great for my products (usually medium risk devices from a biological perspective).

ISO 10993-18:2020 Annex C gives guidance on biological equivalence. Big benefit: No animals needed and you learn how good or bad your products are from a chemical perspective. Section 5 of ISO 10993-18:2020 explicitly points out that chemical characterization can be used for manufacturing process and site changes. 

Kind regards,
Michael

Hello again,
I went through 10993-1:2018 Annex B Clause 4.5.1.and for us it is a material source change e.g., new facility.
Can someone please help me direct on how can I assess risk considerations in this scenario? What clause described further risk assessment to consider for biocompatibility. I know it was mentioned that ISO 10993-18:2020 Annex C gives guidance on biological equivalence that points out chemical characterization that can be used for manufacturing process and site changes. I went through Annex C and still not sure on how the chemical characterization helps compare both sites ( old and new?)  

Thank you!

Dear Anon,

This is mainly dependent on your device type and the extent of manufacturing changes.

Check out ISO 10993-1:2018 Annex B Section B.4.5.1 Changes which can require re-evaluation of biological safety.

If your devices are low risk in respect to biocomp. and the changes do not affect biological aspects (e.g. you transfer all manufacturing equipment as well, use the same operating supplies etc.) then a well documented assessment could work out.

If the changes might introduce any additional biological risk, e.g. you use new machines that might result in other or higher production residues, use new operating supplies, other cleaning agents for your tools etc.,  you should create objective evidence via testing that your devices are still biologically safe.

Over the past couple of years I have worked in several of such transfer projects. Biological equivalence via chemical characterization of extractables/leachables worked out always great for my products (usually medium risk devices from a biological perspective).

ISO 10993-18:2020 Annex C gives guidance on biological equivalence. Big benefit: No animals needed and you learn how good or bad your products are from a chemical perspective. Section 5 of ISO 10993-18:2020 explicitly points out that chemical characterization can be used for manufacturing process and site changes. 

Kind regards,
Michael