The new EU Medical Device Regulation 2017/745 (MDR) has defined more strict criteria for the quality and safety requirements of Medical Devices.
The following areas have been recognized and are specifically addressed as the key fundamentals within the pre-clinical evaluation of medical devices:
In vitro testing expertise to comply with MDR requirements:
Standard and customized in vitro experimental protocols for:
- Demonstration of the mechanism of action of medical devices on 3D reconstructed human tissues
- In vitro penetration, distribution and absorption studies for classification and safety assessment of substance-based medical devices (MDR, Rule 21)