When this applies
At the end of the programme, and again at every submission. ISO 10993-1:2025 expects the biological evaluation to be documented as a reasoned conclusion, not as a folder of test reports. The BER is that conclusion: it is where the endpoint set, the evidence for each, and the residual risk are brought together and signed.
When to run it
Once the evidence is in — testing complete, chemistry assessed, literature searched. Writing it earlier is possible but usually means rewriting it. If you are starting the programme rather than finishing it, the Biological Evaluation Plan (GRK-1001) is the document you want first.
What you receive
A report stating the device categorisation, each endpoint in scope, the evidence route taken for each, the assessment of any residual risk, and a conclusion on biological safety for the intended clinical use — written to be read by a reviewer rather than by a laboratory.
What it does not do
It cannot create evidence that does not exist. Where an endpoint was left open, the report says so explicitly rather than papering over it, because an unstated gap is what triggers a deficiency letter. It also does not remain valid through change: a material, process or indication change means a change impact assessment and, usually, a revised report.
Method
Prepared per ISO 10993-1:2025. The device is categorised by contact type and duration, each applicable endpoint is addressed from the available evidence, and the residual biological risk is assessed and concluded on.
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
The Biological Evaluation Plan it closes out, and a change impact assessment (GRK-1005) whenever the device changes afterwards.
