Biocompatibility & Regulatory FAQ
Expertise you can trust. We answer the most critical questions regarding medical device testing, quality standards, and global submission requirements.
Fundamentals of Biocompatibility
What exactly is biocompatibility in medical device testing?
Biocompatibility refers to the interaction between the tissues and the physiological systems of a patient treated with a medical device. At EBI, we view biocompatibility assessment as a risk assessment study rather than a simple checklist.
- Safety First: The goal is to maximize patient benefits while minimizing biological risks.
- Standardization: We follow the ISO 10993 series, where Part 1 serves as the primary guide for test selection.
- Data Requirements: Biocompatibility data is mandatory for all devices with significant tissue contact. We use the ISO 10993-1 Matrix to determine the exact requirements for your specific device.
Does "addressing biocompatibility" always require laboratory testing?
No. While every medical device must address biocompatibility, not all require physical testing.
- The Software Example: Testing software for biocompatibility is impractical. For such cases, EBI prepares a formal rationale/justification.
- Why it matters: Many 510(k) submissions are rejected simply because the biocompatibility chapter is left empty. A well-prepared rationale meets regulatory requirements without unnecessary lab costs.
When should I re-evaluate biocompatibility for an existing product?
Biocompatibility is not a „one-time” event. Manufacturers must perform a new risk assessment if:
- There is a change in raw materials or suppliers.
- The manufacturing process or machinery is modified.
- The sterilization method is changed.
- New safety data becomes available for existing components.
Quality Systems & Accreditations
Why are ISO 17025 and GLP essential for my reports?
According to ISO 10993-1:2018 (Section B.4.5.3), testing must be conducted in appropriate quality systems.
- GLP (Good Laboratory Practice): A quality system for non-clinical safety studies. It ensures full traceability—allowing for the complete reconstruction of a study. It is mandatory for FDA 21 CFR Part 58 compliance.
- ISO 17025: Standardizes technical requirements to ensure laboratories operate competently and generate valid results.
- EBI Credentials: We are GLP certified, ISO 17025 accredited, and subject to supervision by the European Commission and national Pharmaceutical/Veterinary Inspectorates.
Sample Preparation & Timelines
How many samples do I need to send for testing?
Sample requirements are governed by ISO 10993-12. The amount depends on the device’s surface area, weight, or volume:
- Surface Area Ratio: Typically 6 cm²/mL (for thickness <0.5 mm) or 3 cm²/mL (for thickness ≥0.5 mm).
- Irregular Solids: 0.2 g/mL.
- Note: Complex tests like Sensitization (GPMT) require larger quantities to ensure sufficient extract for the study. Our team provides a precise Sample Submission Form (SSF) during the quotation phase.
How long does the testing process take?
Timelines depend on the biological endpoints being evaluated:
- In Vitro (e.g., Cytotoxicity): 3–6 weeks.
- Chemical Characterization (E&L): 4–8 weeks.
- In Vivo (e.g., Implantation, Sensitization): 8–24+ weeks (due to required observation periods).
- EBI Advantage: Over 96.6% of our reports are delivered before the agreed deadline.
Biocompatibility Evaluation selection Matrix
The matrix classifies devices by Nature of body contact (Surface, Externally Communicating, Implant) and Contact duration:
- Category A: Limited (< 24 h)
- Category B: Prolonged (> 24 h to 30 d)
- Category C: Long term (> 30 d)
Biocompatibility Dictionary (Selected Terms)
AET (Analytical Evaluation Threshold)
The threshold below which an analyst does not need to identify or quantify leachables.
BEP (Biological Evaluation Plan)
The initial document that identifies potential risks and proposes necessary studies.
BER (Biological Evaluation Report)
The final summary explaining why the device is safe for its intended use.
Extractables
Substances released from a device using aggressive laboratory conditions (solvents/heat).
Leachables
Substances that migrate from a device during its normal clinical use.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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