EU MDR and the changing regulatory landscape.
This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of EU MDR, what that means for biocompatibility, and how to ensure your products have adequate evidence.
Approaches for biocompatibility tests such as substances with known carcinogenicity, mutagenicity, and reproductive toxicity for the EU and US regulatory authorities will be covered. We'll go one step further and explore strategies to ensure biocompatibility test results can be leveraged for marketing in multiple geographical regions. We will share several scenarios that will be applicable to small business and big companies alike to demonstrate how manufacturers may leverage clinical evidence to support biocompatibility requirements.