Biological Evaluation of Medical Devices

New for 2019

The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe compliance with the standards will be the easiest way to meet the relevant essential product safety requirements of the Medical Device Regulation. Understanding a risk management approach to biological evaluation is essential.

This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time for interactive discussion with experts in this field.

This seminar will be of importance to those in the medical device industry from the following departments:

• Regulatory affairs
• R&D
• Product safety/toxicology
• Analytical chemistry
• Risk assessment and risk management
• Materials research and evaluation
• It will be of particular interest to Regulatory Authorities, Notified Bodies and CROs regulating or supporting the medical device industry

General principles of biological risk management

• Differences between toxicology and medical device toxicology
• The risk management process according to ISO 14971:2019
• How does ISO 10993 relate to ISO 14971?
• Explanation of structure and core contents of ISO 10993:2018
• Understanding the requirements of ISO 10993-1:2018
• How to navigate through the standard and find applicable sections
• What have we learned from the development of ISO 10993 over the years?

Interactive session: Hazardous situations

Reviewing existing data

• Identifying applicable end points
• Compiling relevant data
• Characterising toxicological hazard from literature review
• Using data on prior use
• Gap analysis – determining the sufficiency of existing datasets
• Developing a Biological Evaluation Plan

Materials characterisation

• Physical and chemical characterisation
• Qualitative vs quantitative evaluation of materials
• Establishing whether additional chemical characterisation is necessary
• Quantification of extractables and leachables
• Limitations of chemical characterisation techniques
• Understand the requirements – goalposts moving with 10993-18:2019
• Biological equivalence – what is it and when is it achieved?

Interactive session: Evaluating chemical data

Quantitative toxicological risk assessment (QTRA)

• Identifying situations in need of QTRA
• Use of ISO 10993-17:2002 and alternative approaches
• Principles of toxicological risk assessment
• The Threshold of Toxicological Concern (TTC)
• Identification of constituents of concern
• Structure activity software
• Risk assessments for constituents, extractables and leachables

Biological testing

• When is biological testing necessary? Identifying uncertainties
• In-vitro vs in-vivo testing
• When is in-vitro testing necessary?
• How to leverage in-vitro results
• Examining ISO 10993-2 animal welfare requirements
• Taking account of the strengths and weaknesses of in-vivo tests
• Developing a test plan

Interactive session: Gap analysis

Risk assessment and control

• Information needed for a risk assessment
• Criteria for risk acceptability
• Risk reduction strategies
• Judging whether the data is sufficient
• Biological Evaluation Reports

Interactive session: Risk reduction

Risk review

• Post-market surveillance data and the biological evaluation profile
• Importance of the feedback loop
• High-profile issues found after CE marking – what lessons can be learned?

Interactive session: Risk review

Q & A discussion

Summary and conclusions