Case studies on 3D reconstructed human tissues
This webinar will showcase the opportunities offered by 3D reconstructed human tissues to demonstrate the physical mode of action of medical devices in line with the requirements and ethical criteria of the EU Medical Devices Regulation (MDR) 2017/745.
Attendees will gain insights into:
💡 How the principles of the 3Rs are applied in the MDR’s requirements.
💡 How 3D reconstructed human tissues become a robust tool to define and demonstrate the principal mode of action of medical devices.
💡 How to assess on a case by case approach the physical mode of action of medical devices according to their different therapeutic areas.
New approach methodologies (NAMs) are driving the transition from animal testing to science-based decision-making for human risk assessment in the life sciences. This transition is aligned with EU Directive 2010/63 on the protection of animals used for scientific purposes and the principles of the 3Rs.
We’ll illustrate how NAMs are applied in the medical devices sector. The principles of the 3Rs were an important source of inspiration for the MDR. ISO 10993 describing the Biological Evaluation of medical devices mandates that appropriate and scientifically validated in vitro methods be preferred over in vivo methods. 3D reconstructed human epidermis tissues can be used to assess skin irritation of medical device components and extracts (ISO 10993-23:2021). Additionally, genomic-based test methods have been demonstrated to be promising solutions for the assessment of the skin sensitization potential of medical devices (ISO 10993-10:2021).
Manufacturers are required to provide scientific proof in their technical file for the qualification of their product as MD (MDCG 2022-5). They need to provide state-of-the-art scientific data regarding the principal mode of action of the MD. By definition, this should be physical, mechanical, or chemical and cannot be pharmacological, immunological, or metabolic. As a result, the demonstration of a physical mode of action became an essential requirement. The film-forming properties and bio-adhesivity of an MD can be demonstrated on 3D reconstructed human tissue models on a case-by-case approach to produce evidence of the MD’s physical mode of action.
VitroScreen has developed and published an experimental procedure on reconstructed human epidermis for film-forming assessment. With this as a basis, we propose protocols optimized for each specific therapeutic area by selecting the tissues on which the MD is intended to act and defining a treatment procedure that mirrors realistic conditions of use. We will present case studies based on different formulation types suitable for gastroenterology, gynecology, ophthalmology, oral care, urology, and the respiratory tract.