When this applies
ISO 10993-1:2025 expects a documented biological evaluation plan before testing starts, and FDA and EU MDR reviewers now ask for it by name. It applies to every device with direct or indirect patient contact: new devices, design changes, new suppliers, and legacy devices being brought into line with the 2025 revision and its lifecycle approach. If you are about to order tests from the ISO 10993-1 tables, this is the document that tells you which of them you actually need.
When to commission it
First — before any test is ordered and ideally while materials are still being chosen. The plan is cheaper than any single animal study, it sets the extraction conditions and sample quantities every test will use, and in practice it removes tests from the list more often than it adds them. Allow ten business days from receipt of inputs for the first draft; one round of consolidated client comments is included.
What you receive
A BEP in Groenakker’s template or yours covering: device description and intended use; categorisation by nature, degree, frequency and duration of contact; a complete inventory of patient-contacting materials with a literature search on up to five of them; the endpoint set per ISO 10993-1:2025 Annex A; for each endpoint the evidence route — test, literature, existing data or justification — with rationale; the testing strategy with extraction conditions; and traceability to the ISO 14971 risk management file. Written to be submitted as-is.
What it does not cover
The base price covers one patient-contacting category (for example externally communicating, tissue/bone/dentin, limited contact) and up to five materials; an additional contact category (GRK-1003) or additional material search (GRK-1004) is priced separately. The Biological Evaluation Report (GRK-1002) that closes the evaluation after testing is a separate deliverable, as are regulatory meetings, responses to questions and further strategy work, which are billed hourly. Urgent requests — delivery in fewer than three business days from receipt — are billed at the standard hourly rate in addition to the base price, and work outside standard business hours (Monday to Friday, 8:00 AM to 5:00 PM ET, excluding observed holidays) at two times the hourly rate; both are subject to availability and confirmed in writing before work starts.
Method
A Biological Evaluation Plan is the risk-based document ISO 10993-1:2025 expects before any biocompatibility testing starts: it categorises the device, inventories every patient-contacting material, sets the endpoints and decides how each will be addressed. Groenakker’s biological safety specialists review the device description, drawings, bill of materials, supplier documentation, manufacturing and sterilisation processes and any existing biocompatibility data; categorise the device under ISO 10993-1:2025; search the published literature for each material; and write the evaluation strategy endpoint by endpoint. The plan is reviewed and approved by a specialist with documented competency per ISO 10993-1:2025, and revised once against your consolidated comments.
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
The Biological Evaluation Report (GRK-1002) once the plan has been executed; chemical characterisation and a toxicological risk assessment where the plan routes endpoints through chemistry; and the baseline tests it almost always keeps — cytotoxicity, sensitization and irritation.
