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Biological Safety Evaluations Under EU's Medical Devices Regulation (PSX 2022 On Demand)

Course Description:
This session will prepare medical device manufacturers to meet the challenges of biological safety requirements, with a focus on the key changes brought about by the European Union's Medical Devices Regulation (MDR), and introduce proactive strategies for integrating carcinogen, mutagen, reproductive toxin, and endocrine disruptor (CMR/ED) substance analysis into the overall biological safety program. This presentation will: discuss the key changes between the EU Medical Device Directive (MDD) and MDR in the context of biological safety, show attendees how to identify applicable articles according to MDR and ISO 10993, perform one-touch supplier interactions to obtain biocompatibility and CMR/ED substance data, and offer practical advice for navigating the expensive and time-consuming process of biocompatibility testing. The presentation is applicable to all direct and indirect patient contacting medical devices.

Contact Hours:
0.5 Contact Hours

Presentation Date:

Lindsey Borton