When this applies
Whenever anything changes: a resin grade, a supplier, a sterilisation cycle, a moulding parameter, an indication. ISO 10993-1:2025 requires the biological evaluation to remain valid for the device as it is actually made, and a change that alters the chemistry alters the evaluation. The reason this exists as a discrete service is that the answer is often no re-testing needed, and establishing that in writing is far cheaper than repeating a battery.
When to run it
Before the change goes into production, not after. A documented pre-change assessment is a controlled decision; the same analysis after the fact is a deviation.
What you receive
An assessment of the change against the existing biological evaluation, stating which endpoints remain supported, which are affected, and whether re-testing is required — with the reasoning documented so it stands up in an audit.
What it does not do
It cannot make a material change biologically equivalent. Where the change does affect the chemistry, the assessment says which endpoints need to be re-addressed rather than concluding otherwise. It also does not update the report itself: a revised Biological Evaluation Report is a separate deliverable.
Method
Assessment per ISO 10993-1:2025. The change is characterised, its effect on each previously addressed endpoint is evaluated, and a re-testing determination is made and justified.
Who performs it
This is performed by Groenakker, not subcontracted. The document is issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system.
Usually ordered alongside
A revised Biological Evaluation Report where the change affects the conclusion, and chemical characterisation where the change needs to be demonstrated as chemically equivalent.
