When this applies
Any change to a device with a completed biological evaluation — a new resin lot or supplier, a colourant, an adhesive, a cleaning agent, a sterilisation cycle, a packaging material, a moulding or coating process. ISO 10993-1:2025 requires the evaluation to be revisited when anything that could affect biocompatibility changes, and reviewers expect the assessment to be documented whether or not testing follows.
When to commission it
As part of the change control, before the change is implemented — the assessment is what tells you whether verification testing belongs in the change plan. Allow one week from receipt of the change description and the existing evaluation.
What you receive
A documented assessment, written to serve as an addendum to the existing biological evaluation or as an attachment to the change order: a description of the change; evaluation of its impact on each biological endpoint using ISO 10993-1 Figure 1 as the framework; a limited-scope risk evaluation; a literature search on any new material; and either a biocompatibility test plan for the affected endpoints or a documented rationale that no testing is needed.
What it does not cover
The testing itself, which is quoted separately, and a full re-evaluation of the device, which is a new plan and report. A change assessment leans on the existing evaluation being sound; where it is not, it says so.
Method
Assesses a device, packaging or manufacturing change against an existing biological evaluation and concludes whether anything needs to be re-tested. Groenakker’s biological safety specialists compare the pre- and post-change device, materials and processes; walk the change through the ISO 10993-1 decision framework; evaluate the affected endpoints against the existing evidence and the literature; and document the conclusion and any test plan under Groenakker’s ISO 13485:2016 quality system.
Who does the work
In-house at Groenakker. The work is authored, reviewed and approved by Groenakker’s biological safety specialists under its ISO 13485:2016 certified quality system, and issued in Groenakker’s template or in your document template on request at no extra cost.
Usually ordered alongside
Whatever the assessment calls for — most often cytotoxicity as a verification screen, chemical characterisation where a material or process residue changed, and the Biological Evaluation Report (GRK-1002) when the file needs to be re-concluded.
