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The EU medical device regulation (MDR) 2017/745 was announced five years ago and will fully apply on May 26, 2021. The new MDR poses major challenges for medical device manufacturers because it imposes strict requirements surrounding the approval process and the time and effort needed to bring new devices to market.
Next to an extensive conformity assessment procedure and extended clinical studies, materials and substances are also a focus of the MDR. Special attention is given to the elimination of carcinogenic, mutagenic, reprotoxic (CMR) substances or endocrine disruptors in medical device materials, in order to fulfill MDR requirements. Through close cooperation, suppliers can support medical device manufacturers in complying with these requirements.
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Our keynote speaker, Stefan Bolleininger from be-on-quality, understands the requirements from a supplier’s point of view and will share insights into these and the necessary testing process to ensure compliance with MDR.
Trelleborg Healthcare & Medical experts, Verena Hörner and Andreas Schmiedel, will take an in-depth look at the Trelleborg MDR strategy and the support provided to medical device manufacturers in meeting MDR material-related requirements, as well as the connection to standards like ISO 10993.
>> Contact us to discuss meeting MDR requirements for your medical device designs