MCRA has extensive experience successfully navigating regulatory biocompatibility expectations for complex medical devices.
What is Biocompatibility Evaluation?
Biocompatibility is the rigorous scientific approach to ensuring that a medical device is compatible with the human body, preventing harm or adverse reactions in clinical use. Biocompatibility Evaluation involves a comprehensive risk management process, assessing multiple device aspects from a biocompatibility standpoint. Biocompatibility Testing is often an important activity within biocompatibility evaluation. However, not all biocompatibility evaluation requires biocompatibility testing.
The first step to biocompatibility evaluation is developing a Biological Evaluation Plan (BEP), which involves examining materials, manufacturing processes, intended clinical use, and associated risks such as chemical toxicity or adverse biological responses. The goal is to minimize unnecessary testing while identifying and mitigating risks to ensure compatibility and balance benefits and risks for patients. The BEP will identify whether the current information available is adequate to evaluate the biocompatibility of the device. If gaps are identified, the BEP will recommend next steps to address the missing information and complete the evaluation. These steps may include paper-based evaluations, such as a toxicological risk assessment or new biocompatibility testing.
A Biological Risk Assessment (BRA) evaluates the totality of information obtained from the BEP, along with new Biocompatibility Testing or new information /analyses gathered to address gaps, and is evaluated by a qualified assessor. The BER document assesses the biological risk associated with the device, which helps manufacturers and regulators make a conclusion about the particular device’s safety and benefit/risk ratio.
Understanding Biocompatibility Regulations
Manufacturers should be aware of the various regulations pertaining to biocompatibility testing for medical devices and their obligations. The regulations in the United States, Europe, and Asia generally conform to the standards set forth in ISO Standard 10993, Biological Evaluation of Medical Devices. However, each geography has its own interpretation of the ISO standards, and some countries do not recognize all aspects of the ISO 10993 standard series. Therefore, it is critical that manufacturers understand the specific requirements of each regulator.
Making sense of these regulatory requirements calls for expert biocompatibility consultants to guide manufacturers through the approval process as smoothly and effectively as possible. Our combined expertise in biocompatibility evaluation and regulatory affairs has helped many clients navigate their biocompatibility assessment responsibilities and avoid pitfalls that can delay new technologies from reaching the marketplace.
Your Biocompatibility Expert
MCRA specializes in comprehensive services to ensure your medical devices are biocompatible, empowering you to confidently bring safe and effective products to market. Our tailored approach to biocompatibility consulting considers the unique aspects of each medical device and conducting a thorough risk assessment that covers the entire lifecycle of your device. Our biocompatibility approach leverages our extensive experience with each regulator’s interpretation of the biocompatibility standards, unlocking more efficient testing strategies than can be developed by reading the standards in isolation. With a team of experienced biocompatibility scientists and toxicologists with past work experience at both FDA and Industry, we are well-versed in global biocompatibility requirements, evaluation of materials, manufacturing processes, and potential risks related to biological safety of medical devices.
MCRA’s streamlined biocompatibility process saves time and strengthens your market position. We provide expertise on regulations, strategy development, compliance with standards, testing design, and toxicological risk assessments. We collaborate closely with you to develop a customized plan for biocompatibility testing, addressing knowledge gaps and providing a clear path to success. Our medical device biocompatibility expertise empowers you to make informed decisions, mitigate risks, and efficiently achieve regulatory compliance.
Let MCRA guide you through the complex world of biocompatibility, ensuring your medical devices are safe and life-changing.
Global Biocompatibility Consulting Services Offered:
- Expertise on global biocompatibility regulations
- Toxicological risk assessment [RA1] (TRA) (ISO 10993-17)
- Biological evaluation plans (BEP) & reports (BER) (ISO 10993-1)
- Chemical characterization (extractables & leachables testing) design and remediation (ISO 10993-18:2020)
- Carcinogenic, Mutagenic, Reproductive toxicity [RA2](CMR) benefit risk assessment
- Response to regulatory deficiencies / nonconformities (FDA, EU Notified Body, PMDA, etc.)
- Risk mitigation strategies for impurities and degradants
- Rationales based on materials and manufacturing in lieu of biocompatibility testing
- Biocompatibility strategy development for new devices, combination products, device changes, material supplier changes
- Gap assessments to the ISO 10993 series of standards and global biological safety standards
- Design of biological testing, test protocol and test report review
- Viral inactivation validation (ISO 22442)
- Liaise with biocompatibility test laboratories to initiate and manage biocompatibility testing
Contact A Biocompatibility Expert
