Presenter: Steve Duckworth (Global Head Marketing and Business Development at Clariant)
MDR/IVDR makes it essential for OEMs to understand what substances are in their devices. This pattern is repeated in impending USP regulations to use so-called ‘well-characterized materials’. Faced with these questions, and a growing list of ‘substances of concern’, how will you be in compliance ? The usual approach of ask my suppliers ‘Does it contain XYZ?’ is likely to result in some surprising answers! Maybe you feel you don’t have a necessary depth of plastics materials knowledge? Does this mean I need to test for everything? A good ‘risk management’ strategy is first to understand what information is possible to have and what not. In this presentation we look at the practical challenges you will face to get the answers you will need. Also how MedPharmPlast Europe and its ‘vertical expertise’ can help overcome these challenges and tap into the 100’s of years of combined plastics and regulatory know how.
The presentation was recorded at our Open House Event in Leuven on 4 March.