Biological evaluation of Medical Devices

This course provides you with fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed. This course outlines the structure of the biological evaluation and how to plan and conduct a biological evaluation within a risk management process. The course will also provide you with a working knowledge of the different biological tests available, as well as important aspects to think of when it comes to ordering/performing tests for the biological evaluation.

With the revisions of ISO 10993 part 1 and 18 in 2018 and 2020, respectively, and the recently completed revision, more emphasis is put on material characterization and a risk-based approach. In addition, MDR also sets higher demands on substances contained in and released from devices. The course will provide you with a basic understanding of the chemical characterization process and toxicological risk assessment framework. The course content is illustrated with our own experiences from testing and evaluation of medical devices for biocompatibility, as well as experiences from interactions with notified bodies and other authorities.

After this course you will have increased knowledge about the requirements on biological safety that your finished product will need to fulfill, and an understanding both of how this evaluated and how it is documented for review by authorities. You will also get familiar with the tools to be used to perform the assessment within a risk management process.

The course is a basic course intended to give a broad overview of the area. See also our advanced course for already experienced professionals, with deep-dives into how to perform toxicological evaluations, more information on available in vitro tests and strategies to reduce the amount of animal tests, and more detailed and in-depth knowledge in all areas mentioned above.

Course content

Day 1 – Basics of biological evaluation where we, among other things, review the following topics
(13.00 – 16.30 CET):

• What is biocompatibility and why is a biological evaluation needed?
• The relation between ISO 10993 and the risk management standard ISO 14971
• Biological tests – overview of different parts of ISO 10993
• Structure of the biological evaluation
• Can animal tests be avoided?
• MDR, FDA and biocompatibility
• ”Common pitfalls” – avoid the typical mistakes
• Group discussions with practical examples for exercises

Day 2 – Practical aspects of testing, Material characterization and toxicological evaluation,
focus on ISO 10993-12, -17 and -18 Biological evaluation in more depth, including among others:
(13.00 – 16.30 CET)

• Sample preparation (ISO 10993-12) and what you should consider in the communication with the test-house
• Chemical characterization in accordance with ISO 10993-18
• Overview and selection of chemical testing methods for material characterization and the use of results
• Points to consider when using chemical characterization to reduce the number of animal tests
• Toxicological risk assessments, part 17 – Basics on performance and important points to consider
• ISO/FDIS 10993-17– expected changes to current part 17
• Group discussions with practical examples for exercises

Who should attend

Everyone who needs an understanding of the biological evaluation requirements, e.g. professionals working with design and development, project management, regulatory affairs or quality assurance. The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer’s needs and requirements.

Previous knowledge level

To be able to grasp and make use of the course content you should have basic knowledge of medical devices and the associated regulations.

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