Biocompatibility and Toxicological Risk Assessment of Medical Devices - The Notified Body Perspective
Building Compliant Biological Safety Evaluations for Medical Devices.
Biocompatibility is a fundamental requirement for demonstrating the safety of medical devices and achieving global regulatory compliance. This training provides a practical and comprehensive understanding of biological safety evaluation in accordance with ISO 10993-1:2025 and toxicological risk assessment according to ISO 10993-17:2023, including current expectations from a Notified Body perspective.
Participants will learn how to develop risk-based biological evaluation strategies, perform device categorization, assess chemical and toxicological risks, determine testing needs, and prepare biocompatibility documentation that supports regulatory submissions under MDR 2017/745. Through practical examples, case studies, and real-world evaluation scenarios, attendees will gain valuable insight into what Notified Bodies expect during technical documentation assessments.
Upon completion of this training, participants will be able to:
- Explain the regulatory framework governing biocompatibility evaluations
- Interpret ISO 10993-1:2025 requirements and recent updates
- Apply risk management principles to biological evaluations
- Categorize medical devices according to body contact type and duration
- Identify applicable biological effects for a medical device
- Develop Biological Evaluation Plans (BEPs)
- Conduct gap analyses and assess state-of-the-art compliance
- Evaluate chemical and physical information relevant to biological safety
- Understand extractables and leachables studies
- Apply concepts from ISO 10993-18 chemical characterization
- Understand toxicological risk assessment processes under ISO 10993-17
- Interpret Margin of Safety (MoS) and Threshold of Toxicological Concern (TTC)
- Select appropriate biological testing strategies
- Assess the biological safety of devices throughout the product lifecycle
- Develop Biological Evaluation Reports (BERs) that support regulatory submissions
- Understand common Notified Body findings and compliance pitfalls
Testimonials:
- "It was educational and informative. Speaker was very knowledgeable."
- "The course was very useful and covered most of the questions and doubts about Biocompatibility Evaluation conductance for a medical device manufacturer."
This course is intended for:
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Medical Device Manufacturers
- Biological Safety Specialists
- Biocompatibility Engineers
- Toxicologists
- R&D Engineers
- Product Development Engineers
- Design Assurance Professionals
- Risk Management Specialists
- Technical Documentation Authors
- Clinical Affairs Professionals
- Validation Specialists
- Internal and External Auditors
- Consultants supporting medical device regulatory compliance
The course will cover the following topics:
- Basic biocompatibility concepts
- Biocompatibility testing strategies
- Updates on revised standards
- Biocompatibility assessment from the Notified Body perspective, according to ISO 10993-1:2025
- Toxicological risk assessment according to ISO 10993-17:2023
Section A – Regulatory Requirements and Standards
- Regulatory framework for biological evaluation
- MDR 2017/745 requirements and GSPRs
- State-of-the-art expectations
- Harmonized versus non-harmonized standards
- Overview of the ISO 10993 series
- Horizontal and vertical biocompatibility standards
- Common regulatory pitfalls
Section B – Biological Evaluation as a Structured Program
- ISO 10993-1:2025 updates
- Risk-based biological evaluation
- Device categorization
- Biological effect identification
- Chemical and physical information collection
- Gap analysis methodologies
- Existing data assessment
- Biological equivalence
- Biological Evaluation Plans (BEPs)
- Biological Evaluation Reports (BERs)
- Lifecycle considerations
- Change control and biological re-evaluation
Section C – Chemical Characterization and Toxicological Assessment
- ISO 10993-18 overview
- Test article selection and preparation
- Extractables and leachables
- Extraction methodologies
- Analytical techniques
- Analytical Evaluation Threshold (AET)
- Chemical characterization workflow
- Toxicological Risk Assessment according to ISO 10993-17
- Threshold of Toxicological Concern (TTC)
- Margin of Safety (MoS)
- Toxicological risk interpretation
- Common assessment pitfalls
Section D – Biological Testing and Evaluation
- Biological testing strategy
- Cytotoxicity
- Sensitization
- Irritation
- Material-mediated pyrogenicity
- Systemic toxicity
- Implantation effects
- Hemocompatibility
- Genotoxicity
- Carcinogenicity
- Reproductive and developmental toxicity
- Biological effect coverage and test justification
- CMR and endocrine disruptor considerations
- Common testing pitfalls
Practical Activities
- Knowledge checks
- Device case studies
- Group discussions
- Regulatory interpretation exercises
- Real-world Notified Body review scenarios
Biocompatibility evaluation is a critical component of medical device development and regulatory approval. As regulatory expectations continue to evolve, manufacturers must demonstrate biological safety using a structured, risk-based approach that aligns with current standards and state-of-the-art scientific principles. ISO 10993-1:2025 introduces significant updates that further integrate biological evaluation into the overall risk management process and place greater emphasis on scientific justification, lifecycle considerations, and chemical characterization.
This intensive training provides a detailed overview of biological evaluation according to ISO 10993-1:2025 and toxicological risk assessment according to ISO 10993-17:2023. Participants will learn how to categorize medical devices, identify applicable biological effects, gather relevant data, perform gap analyses, establish Biological Evaluation Plans (BEPs), and prepare Biological Evaluation Reports (BERs). The course also explains how biological evaluation supports compliance with EU MDR 2017/745 and current Notified Body expectations.
The training further explores chemical characterization in accordance with ISO 10993-18, including extractables and leachables studies, analytical testing strategies, Analytical Evaluation Threshold (AET) calculations, and toxicological assessment methodologies. Participants will understand how chemical data are translated into biological risk assessments through Margin of Safety (MoS), Threshold of Toxicological Concern (TTC), and exposure-based evaluation approaches.
In addition, the course explains biological testing approaches for cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, implantation effects, genotoxicity, carcinogenicity, reproductive toxicity, and other biological endpoints. Attendees will gain insight into when testing is required, when existing data may be leveraged, and how to justify testing strategies using a risk-based approach.
Through expert instruction, interactive discussions, case studies, practical exercises, and knowledge checks, participants will gain practical knowledge to establish robust biological evaluation programs, address common compliance gaps, and better prepare technical documentation for regulatory submissions and Notified Body review.
This training will provide participants an insight of ISO 10993-1: 2025, (Requirements and general principles for the evaluation of biological safety within a risk management process) and ISO 10993-17:2023 (Biological Evaluation of Medical Devices – Establishment of allowable limits for leachable substance). It will be helpful for Quality and Regulatory people who are involved in preparing technical files and Design Dossiers. It gives a hands-on experience/knowledge of Biocompatibility assessment, testing strategy and Risk Assessment Approach.
Participants will:
- Understand ISO 10993-1:2025 biological evaluation requirements
- Interpret ISO 10993-17:2023 toxicological risk assessment requirements
- Understand EU MDR biocompatibility expectations and GSPRs
- Learn current Notified Body expectations for biological safety documentation
- Develop risk-based biological evaluation strategies
- Build stronger Biological Evaluation Plans (BEPs)
- Improve Biological Evaluation Reports (BERs)
- Learn device categorization and biological effect selection
- Understand chemical characterization requirements under ISO 10993-18
- Apply extractables and leachables concepts
- Understand AET, TTC, TI, TCL, and MoS calculations
- Evaluate biological risks throughout the device lifecycle
- Improve technical documentation quality and submission readiness
- Reduce deficiencies, questions, and nonconformities during audits and reviews
- Gain practical knowledge through case studies and real-world examples
This instructor-led training is delivered in a live virtual classroom environment and combines:
- Expert-led presentations
- Practical examples
- Real-world case studies
- Interactive discussions
- Regulatory interpretation exercises
- Group activities
- Knowledge checks and quizzes
- Question-and-answer sessions
- Notified Body perspective insights
Participants can interact directly with the instructor and peers throughout the course to discuss practical implementation challenges and regulatory expectations.
Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy.
Recommended but not mandatory:
- Basic knowledge of medical devices
- Understanding of quality management systems
- Familiarity with regulatory requirements
- Basic understanding of biocompatibility concepts
Experience in biocompatibility, toxicology, regulatory affairs, quality assurance, or product development is beneficial.
What standards are covered in this training?
The training focuses primarily on ISO 10993-1:2025 and ISO 10993-17:2023, while also addressing related standards such as ISO 10993-18 and MDR 2017/745 requirements.
Does the course include the latest ISO 10993-1:2025 updates?
Yes. Participants will learn the key changes introduced in ISO 10993-1:2025 and their impact on biological evaluations.
Is this course focused on testing only?
No. The course emphasizes a risk-based biological evaluation process, including data assessment, chemical characterization, toxicological assessment, documentation, and testing strategies.
Will chemical characterization be covered?
Yes. The course includes chemical characterization concepts, extractables and leachables, analytical methods, and AET calculations.
Does the training explain toxicological risk assessment?
Yes. Participants will learn toxicological risk assessment fundamentals according to ISO 10993-17:2023, including TTC and Margin of Safety concepts.
Will Biological Evaluation Plans and Reports be discussed?
Yes. The course explains how to prepare and maintain both BEPs and BERs.
Does the training include MDR requirements?
Yes. MDR 2017/745 biological safety requirements and relevant GSPRs are discussed.
Is the course suitable for Regulatory Affairs professionals?
Absolutely. The course is highly relevant for Regulatory Affairs professionals preparing technical documentation and regulatory submissions.
Does the course provide a Notified Body perspective?
Yes. A key focus of the course is understanding how Notified Bodies assess biocompatibility documentation and common deficiencies seen during reviews.
Are case studies included?
Yes. The course contains practical exercises, case studies, knowledge checks, and real-world evaluation scenarios.
Do participants receive a certificate?
Yes. Participants who successfully complete the training receive a TÜV SÜD certificate.
Is the course appropriate for both beginners and experienced professionals?
Yes. The training is suitable for individuals new to biocompatibility as well as experienced professionals seeking to update their knowledge of current regulatory expectations and standards.
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