Learn effective and practical approaches that meet EU medical device regulation (MDR) requirements, and how to update them based on notified body .. Read more feedback. Delve into detailed press kits for information on our work. As the global safety science leader, UL helps companies to demonstrate safety, enhance sustainability, strengthen security, deliver quality, manage risk and achieve regulatory compliance. Explore our business intelligence-building digital tools and databases, search for help, review our business information, or share your concerns and questions. Section of 10.4.1 of the EU Medical Device Regulation (EU MDR) requires identification of carcinogens, mutagens and reproductive toxins (CMRs) and endocrine-disrupting chemicals (EDCs) over 0.1% w/w in invasive, or fluid or gas contacting materials. There is no one standard format for the output requirements.
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