Bioexcelife
Biological safety is one of the most important parts of medical device compliance under EU MDR.
If your device comes into direct or indirect contact with the human body, regulators and Notified Bodies will expect you to show that the materials are safe for the intended use.
This is where ISO 10993 becomes critical.
ISO 10993 is the key standard series used for the biological evaluation of medical devices. The latest ISO 10993-1:2025 defines requirements and principles for evaluating biological safety within a risk management process. It also connects biological evaluation with ISO 14971 risk management thinking.
Why ISO 10993 Matters Under MDR
Under MDR, manufacturers cannot simply say a material is “biocompatible.” They must provide evidence.
The biological evaluation must consider the device’s intended purpose, type of body contact, duration of contact, material composition, manufacturing residues, and potential biological risks.
In practice, this means ISO 10993 is not just about testing. It is about building a clear scientific justification for biological safety.
A strong biological evaluation helps answer one key question:
Can this device safely contact the human body during its intended use?
ISO 10993 Is Not a Testing Checklist
Many manufacturers make the mistake of treating ISO 10993 as a fixed list of tests.
That approach can create unnecessary testing, extra cost, and weak documentation.
The standard expects a risk-based approach. This means you first understand the device, materials, contact type, exposure duration, and available evidence. Then you decide what testing or justification is actually needed.
For example, a short-term skin-contact device will not need the same biological evaluation as a long-term implant.
The evaluation should match the risk.
The Role of Biological Evaluation Plan and Report
For MDR submissions, the biological safety file usually includes a Biological Evaluation Plan (BEP) and a Biological Evaluation Report (BER).
The BEP defines the strategy. It explains what data is needed, what endpoints are relevant, and whether testing, literature, chemical characterization, or toxicological assessment will be used.
The BER then brings the evidence together. It explains whether the device is biologically safe and whether any remaining biological risks are acceptable.
This is the part Notified Bodies review closely.
If the BEP and BER are weak, unclear, or disconnected from risk management, questions are likely.
What Notified Bodies Expect
Notified Bodies expect biological evaluation to be logical, traceable, and aligned with MDR requirements.
They want to see that the manufacturer has identified relevant biological risks and justified the evidence used to control them. They also expect the evaluation to align with material information, manufacturing processes, sterilization, packaging, shelf life, and clinical use.
If a device uses new materials, has prolonged contact, or contains substances of concern, the level of scrutiny increases.
In short, Notified Bodies want a scientific argument, not a generic statement.
Common Mistakes Manufacturers Make
One common mistake is submitting old biocompatibility test reports without checking whether they still match the current device design, material supplier, manufacturing process, or MDR expectations.
Another mistake is missing chemical characterization or toxicological risk assessment where it is needed. In recent regulatory practice, there is growing emphasis on material characterization and toxicological justification, especially for devices with significant body contact.
Manufacturers also face issues when biological evaluation is not linked with the risk management file. Under ISO 10993-1, biological safety evaluation sits within the broader risk management process, so it should not be treated as a separate document.
Why the 2025 Update Matters
The 2025 version of ISO 10993-1 strengthens the focus on risk-based biological safety evaluation and lifecycle thinking. Industry summaries of the update highlight stronger attention to material characterization, exposure-based assessment, foreseeable use factors, and better alignment with MDR expectations.
For MDR manufacturers, this means biological safety files may need review. A file that passed years ago may not automatically meet current expectations.
What Manufacturers Should Do Now
Manufacturers should review their biological evaluation strategy early in the technical documentation process.
Start by checking whether the device contact category is correct. Then review material composition, supplier changes, manufacturing residues, sterilization effects, and available test data.
Most importantly, check whether your biological evaluation clearly links to risk management and MDR Annex I safety requirements.
A strong ISO 10993 strategy can reduce Notified Body questions, avoid unnecessary testing, and support faster review.
ISO 10993 is not just a biocompatibility testing standard. It is a framework for proving biological safety through risk-based evidence.
For MDR manufacturers, the goal is not to perform every possible test. The goal is to build a clear, scientific, and defensible biological safety justification.
When done properly, ISO 10993 supports patient safety, strengthens technical documentation, and improves audit readiness.
How Bioexcel Can Help
At Bioexcel, we support medical device manufacturers with ISO 10993 biological evaluation, BEP and BER preparation, toxicological risk assessment, gap review, and MDR technical documentation alignment.
We help ensure your biological safety evidence is clear, compliant, and Notified Body-ready.
Need support with ISO 10993 biological evaluation under MDR? Partner with Bioexcel for a stronger and safer compliance strategy.
