When this applies
When the endpoint needs a safety conclusion and E&L testing has not been done — a legacy device, an inherited file, a submission timeline that will not accommodate a chemistry campaign. ISO 10993-17:2023 permits an assessment built from composition and published data; what it does not permit is presenting that assessment as though it rested on measurement.
When to run it
When testing is genuinely not available. If chemistry is an option, run it first and commission the standard assessment (GRK-2001) instead — a conclusion built on measured extractables is materially stronger, and the difference shows in review.
What you receive
An assessment built from material composition, supplier data and published toxicological data, with each constituent evaluated against its tolerable exposure — and the residual uncertainty from the absence of E&L data stated explicitly. That explicit statement is the point: it is what makes the document defensible rather than optimistic.
What it does not settle
It cannot rule out a constituent that composition data does not disclose — degradation products, process residues and contaminants are precisely what E&L testing exists to find. Reviewers know this, and where the uncertainty is material the assessment may conclude that testing is required after all.
Method
Assessment per ISO 10993-17:2023 from material composition, supplier declarations and published toxicological data, for the device’s clinical use, contact duration and patient population, with residual uncertainty stated.
Who performs it
This is performed by Groenakker, not subcontracted. The assessment is authored and signed by a board-certified toxicologist and 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 material literature search (GRK-1004) to strengthen the published-data basis, and chemical characterisation where the uncertainty turns out to be material.
