Biological Evaluation Report (BER)
Biological evaluation Report is an important conclusive final stage of the biocompatibility assessment process. This report gets incorporated into your clinical evaluation report as well.
In today’s competitive medical device world multiple changes to the regulations and constant additions to the Medical device safety and new rising safety risks adding a constraint to the innovations and established medical products worldwide.
That’s why your Biological Evaluation Report (BER) is not just a regulatory document, in our view it must have engineered regulatory longevity. Every BER created must be built with the foresight of upcoming ISO revisions, MDR and FDA alignments, ensuring your documentation remains relevant and risk-secure for years ahead.
At Cormica, we follow ISO 10993 requirements and transform the BER into clear and defendable narratives that regulators trust and manufacturers rely on.
What Is a Biological Evaluation Report (BER)?
A Biological Evaluation Report (BER) is a comprehensive, evidence-based report that brings together all existing and additional biological and chemical data, test results, justifications, and risk assessments to demonstrate that your device is safe for its intended use, it’s your scientific passport to regulatory approval.
The BER includes:
- Executive summary of the device and intended use
- Evaluation of materials, manufacturing, sterilization, and packaging
- Analysis of biological risks and hazard identification
- Review of test results, chemical characterization, and TRAs
- Risk assessment in alignment with ISO 14971
- Justifications for test waivers, equivalence
- A final scientific conclusion on biological safety
Each BER we author is backed by qualified biocompatibility experts and TRAs made by toxicologists ensuring precision, transparency and global regulatory acceptance.
A well-structured BER gives regulators exactly what they need – a conclusive summary of biological safety! Our BER document anticipates most of the reviewer’s questions before they ask. Our risk-based approach ensures each biological endpoint is relevant and is addressed with clear rationale, saving you weeks or months in review.
Avoid Redundant Testing, Reduce Costs
Our BERs build on the BEP to leverage existing data and chemical characterization, helping you to avoid repetitive, unnecessary/overlapping tests. Fewer studies. Fewer animals. Fewer invoices. All will maximum safety to the Patient.
Enhance Patient Safety and Brand Integrity
The BER identifies and closes biological risk gaps long before they turn into product recalls or reputational damage. From cytotoxicity to systemic safety, BER becomes a declaration of reliability and ethical responsibility.
What BER Looks Like
- Device Description & Intended Use – Every detail: materials, manufacturing, sterilization, packaging, and clinical purpose. We turn your technical specifications into a biological risk portrait that regulators can easily follow.
- Biological Risk Assessment – We identify biological hazards linked to your materials, duration of use, and patient population supported by literature, data, and chemical analysis.
- Data Integration & Testing Review – From ISO 10993-5 cytotoxicity to ISO 10993-17 TRA, we integrate all studies into a unified laboratory findings with toxicological interpretation.
- Gap Analysis & Justification – We identify missing data, evaluate equivalence with predicate devices, and justify waivers scientifically.
- Biological Risk Evaluation & Control – All biological risks are quantified, evaluated, and mitigated using ISO 14971 principles resulting in an auditable, regulator-ready conclusion.
- Final Safety Statement – The report concludes with a concise and comprehensive verdict: “Based on the available data, testing, and risk evaluation, the device is considered biologically safe for its intended purpose and foreseeable misuse.”
Why Choose Cormica for Your BER?
- Authored by certified and experienced biocompatibility specialists
- Fully aligned with ISO 10993-1, ISO 14971, EU MDR, UK MDR and FDA guidance.
- Proven success across implantable, respiratory, and diagnostic devices
- Delivered with scientific clarity and regulatory storytelling finesse and transparent efficiency.
Cormica don’t tailor report just for the present quarter, we craft it as a regulatory jacket potentially fitting for decades, shielding you from costly rework, repeated gap analyses and retesting as standards evolve as far as predictably possible.
We thrive to make your data to be your defence and strong evidence of patient’s safety. Your innovation deserves a flawless biological story. Let’s write it together, let’s write it best.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Cormica's Support and Consultancy Services
Regulatory Consultancy
- ISO 10993 Biocompatibility Testing
- Biological Evaluation Plans (BEP)
- Biological Evaluation Reports (BER)
- Clinical Evaluation Plans (CEP) & Reports (CER)
- US FDA Submission Support
- UK & EU MDR Submission Support
- Toxicological Risk Analysis
- Biological Gap Analysis
- Post-Market Surveillance (including PSUR)
Development & Lifecycle Support
- Materials Selection & Collection
- Supply Chain Support
- Packaging Consultancy
- Design & Verification Support
- Late-Stage Development Issue Resolution
- Pack Market Remediation
Our Clients’ Experiences
