Presentation

The GARD®skin Medical Device assay for assessing the skin sensitizing potential of medical devices: A case study on the use of in vitro data in the biological evaluation for CE marking according to MDR

Key Points

• A proof-of-concept study using the GARD®skin Medical Device assay to evaluate the skin sensitizing potential of medical device materials according to ISO 10993-10.
• A case study using in vitro data for the endpoints of cytotoxicity, skin irritation and skin sensitization in the biological evaluation for CE-marking according to MDR to avoid animal testing while accelerating time to market.