How do medical device manufacturers reliably demonstrate the biological safety of their products in accordance with ISO 10993?
We support the biocompatibility evaluation from risk assessment through the Biological Evaluation Plan per ISO 10993-1:2018 to the audit-ready Biological Evaluation Report for the technical documentation under MDR (EU) 2017/745. The decisive factor is the evaluation logic of the standard: first review existing material and literature data and the chemical characterization per ISO 10993-18, then test biologically in a targeted manner. The most expensive mistake is not a missing test, but a testing strategy that starts without prior chemical characterization and has to repeat studies because the material data do not hold up.
- MedTech
- IVD
Overview
Which biocompatibility requirements arise in MedTech development?
Biocompatibility evaluation per ISO 10993-1:2018 · chemical characterization per ISO 10993-18 · Biological Evaluation Report for the MDR (EU) 2017/745
Last updated: 2026-06-13
ISO 10993 is the series of standards for the biological evaluation of medical devices. ISO 10993-1:2018 shifted the evaluation approach: away from a fixed catalog of tests and toward a risk-based evaluation within the risk management process per ISO 14971, in which material and literature data as well as chemical characterization rank on equal footing with biological tests. The points where evaluations typically get stuck:
- ISO 10993-1:2018 requires a documented risk assessment across all relevant biological endpoints before tests are selected. The nature and duration of body contact determine which endpoints need to be addressed in the first place.
- Chemical characterization per ISO 10993-18 is too rarely used as the first step, even though it underpins the toxicological risk assessment and can replace or justify biological tests in a targeted way.
- Biocompatibility evaluations are often based on an older edition of the standards and do not reflect the evaluation logic of ISO 10993-1:2018; older reports do not address all endpoints required by the nature and duration of contact.
- Changes to materials, cleaning, sterilization, or suppliers trigger a new risk assessment; without a link to change control, the gap only surfaces during the review of the technical documentation.
- MDR (EU) 2017/745 Annex I requires demonstration of biological safety as part of the General Safety and Performance Requirements. The Biological Evaluation Report must be integrated into the technical documentation.
Services
How we support you
Risk Assessment & Biological Evaluation Plan (BEP)
Preparation of a Biological Evaluation Plan per ISO 10993-1:2018: categorization of the device by nature and duration of contact, definition of the relevant biological endpoints, and risk-based justification of which endpoints are addressed through data, characterization, or testing. The deliverable is an agreed, audit-ready BEP.
Chemical Characterization per ISO 10993-18
Planning and support of chemical characterization as the basis for the toxicological risk assessment. Selection of suitable test laboratories, definition of the characterization scope, and review of the reports. The deliverable is an evaluated data set that justifies or replaces biological tests.
Biological Testing & Laboratory Coordination
Selection of accredited test laboratories for biological endpoints per ISO 10993, coordination of in-vitro and in-vivo studies, and review of test protocols and results reports before they are incorporated into the evaluation. The deliverable is robust test reports integrated into the BEP.
Biological Evaluation Report (BER)
Preparation of the Biological Evaluation Report per ISO 10993-1:2018, consolidating material and literature data, chemical characterization, and biological test results. The deliverable is a BER that can be integrated directly into the technical documentation under MDR (EU) 2017/745.
Learn more →How we work together
What it comes down to
The biological evaluation per ISO 10993-1:2018 is not a catalog of tests to be worked through, but a decision about sequence. First, the risk assessment determines, based on the nature and duration of contact, which biological endpoints are relevant at all. Then, for each endpoint, it is decided whether it is closed out through existing material and literature data, through the chemical characterization per ISO 10993-18, or through a biological test. Reversing this sequence and commissioning tests early loses chemical characterization as the gating step. Without it, the basis of the toxicological risk assessment is missing, and studies must be repeated as soon as substances emerge that the original plan did not capture.
This is precisely where we come in: at the outset, the Biological Evaluation Plan makes visible which endpoints are supported by data and characterization and which require a test, before laboratory capacity is booked. This shifts the effort forward into the evaluation rather than into repeated studies. Because ISO 10993-1:2018 embeds the biological evaluation in risk management per ISO 14971, the Biological Evaluation Report stays linked to the risk analysis and therefore remains audit-ready for the technical documentation under MDR (EU) 2017/745.
Our approach
Our approach
Step
Result
Risk Assessment
Documented categorization by nature and duration of contact with a list of the relevant biological endpoints, derived from risk management per ISO 14971.
Biological Evaluation Plan
Agreed BEP per ISO 10993-1:2018: for each endpoint, it is defined whether it is addressed through data, chemical characterization, or testing.
Chemical Characterization
Characterization data per ISO 10993-18, evaluated as the basis for the toxicological risk assessment.
Biological Testing
Coordinated and reviewed test reports for the remaining endpoints from accredited laboratories.
Biological Evaluation Report
Audit-ready BER that closes all endpoints and is integrated into the technical documentation.
Common pitfalls
Where projects commonly fail
The testing strategy starts without chemical characterization.
If biological tests are commissioned before the material data per ISO 10993-18 are available, the basis for the toxicological risk assessment is missing, and studies must be repeated as soon as substances emerge that the original plan did not cover.
The Biological Evaluation Plan does not address all endpoints relevant under ISO 10993-1:2018.
Defining the nature and duration of contact too narrowly overlooks required endpoints; the gap only becomes visible during the review of the technical documentation and forces additional requests.
Changes to materials, cleaning, or sterilization are not treated as triggers for a new evaluation.
Without linking biocompatibility to change control, the evaluation becomes outdated unnoticed, even though the biological risk profile has changed.
The evaluation sits alongside risk management instead of within it.
ISO 10993-1:2018 embeds the biological evaluation in the risk management process per ISO 14971; a BER without a link to the risk analysis meets the requirement only formally and is flagged during review.
Supplier or material data are adopted without scrutiny.
Data sheets with no relation to the specific nature of contact and the processing state of the finished product do not support the evaluation; the data must relate to the finished, cleaned, and sterilized product.
FAQ
Frequently asked questions
Sources
- ISO 10993-1:2018: Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process
- ISO 10993-18: Biological evaluation of medical devices, Part 18: Chemical characterization of materials
- ISO 14971: Application of risk management to medical devices
- Regulation (EU) 2017/745 (MDR): primary text, Annex I
- Entourage Website Writer source material: Biocompatibility Studies (as of 2026-03-29)
- https://theentourage.de/expertise/biocompatibility-studies/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- ISO 10993-1:2018 (evaluation and testing of medical devices within a risk management process)
- ISO 10993-18 (chemical characterization of materials)
- ISO 14971 (application of risk management to medical devices)
- EU 2017/745 (MDR)
- MDR Annex I (General Safety and Performance Requirements, GSPR)
- EU 2017/746 (IVDR)
Related topics
Risk Management →
ISO 14971 as the framework into which ISO 10993-1:2018 embeds the biological evaluation
Design Controls →
Material and process decisions that determine the biological risk profile
Verification & Validation →
Biological testing as an element of evidence in the V&V plan
MDR Conformity →
Integration of the Biological Evaluation Report into the technical documentation under MDR (EU) 2017/745
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