Biological Evaluation Report (BER) – ISO 10993-1
Ensure full regulatory compliance for your medical device with a professional BER—the cornerstone of biological safety and MDR certification.
The Biological Evaluation Report (BER) is a mandatory technical document that summarizes all biological evidence gathered to prove your device is safe for human use. It is not merely a collection of test results; it is a comprehensive safety narrative that justifies why your device will not cause harm to patients or users. At EBI, our expert assessors synthesize laboratory data, clinical literature, and risk analysis into a submission-ready report that satisfies Notified Bodies and regulatory authorities worldwide.
Why is a BER Essential for Your Device?
Whether you are launching a new product or maintaining an existing one, a BER is a vital part of your validation process. It is required for:
- New Product Submissions: Proving safety before market entry.
- Material Changes: Assessing risks when a component or supplier changes.
- Regulatory Updates: Filling gaps in legacy documentation to meet current MDR 2017/745 standards.
- Compliance: Demonstrating that all evaluations conform to the rigorous requirements of ISO 10993.
Our Biological Evaluation Strategy
Following the ISO 10993-1 framework, EBI experts guide you through a structured decision-making process to minimize unnecessary testing and maximize data integrity.
1. Material & Device Characterization
We begin by identifying the chemical composition of your device and its manufacturing history. We determine:
- Nature of Contact: Does the device contact skin, mucosal membranes, or internal tissue?
- Duration of Contact: Is the contact limited (<24h), prolonged, or permanent?
2. Gap Analysis & Literature Review
We evaluate existing data to identify what is already known about your materials. If a material has a long history of safe use in similar applications, we provide a scientific rationale to justify why further testing may not be necessary, saving you time and costs.
3. Biological Risk Assessment
We identify potential biological risks and define the necessary test plan (if gaps exist) to mitigate those risks. This includes a statement confirming that all risk controls have been successfully completed.
4. Final Assessment & Statement
The process concludes with a formal statement by our qualified experts, confirming that the medical device meets the biological safety requirements of the intended application.
The EBI Evaluation Workflow
Our methodology follows the standardized flowchart for biological evaluation:
- Initial Start: Does the device contact the body directly or indirectly?
- Evaluation Path: If „Yes,” we proceed to material characterization and check if the material is the same as in existing commercially available devices.
- Testing & Rationale: We select the necessary biological tests or provide a rationale justification for why certain data isn’t needed.
- Final Assessment: A definitive conclusion on whether the device meets the ISO 10993-1 standard.
Standards & Compliance
EBI’s experts have the specific qualifications and experience required to interpret complex data and guide you through the regulatory landscape. All reports are authored in strict accordance with:
- ISO 10993-1: Evaluation and testing within a risk management process.
- MDR 2017/745: European Medical Device Regulation requirements.
- ISO 14971: Application of risk management to medical devices.
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.
FAQ
Who should write the Biological Evaluation Report?
According to ISO 10993, the report must be carried out by suitably qualified and experienced persons. Our team at EBI consists of expert assessors specialized in biocompatibility and toxicology.
What is a „Rationale” in a BER?
A rationale is a documented scientific justification explaining why a specific biological test (e.g., a 2-year implantation study) is not required based on existing data, material history, or chemical characterization.
Is a BER required for non-contacting devices?
If a device has no direct or indirect contact with the patient’s body, the ISO 10993-1 standard may not be applicable. However, a brief statement or report confirming this „non-contact” status is often required for the technical file.
Who should write the Biological Evaluation Report?
According to ISO 10993, the report must be carried out by suitably qualified and experienced persons. Our team at EBI consists of expert assessors specialized in biocompatibility and toxicology.
What is a "Rationale" in a BER?
A rationale is a documented scientific justification explaining why a specific biological test (e.g., a 2-year implantation study) is not required based on existing data, material history, or chemical characterization.
Is a BER required for non-contacting devices?
If a device has no direct or indirect contact with the patient’s body, the ISO 10993-1 standard may not be applicable. However, a brief statement or report confirming this „non-contact” status is often required for the technical file.
Contact with us
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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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