In this webinar, NAMSA’s regulatory and testing experts will discuss the restricted materials compliance sections of the Medical Device Regulation (MDR), specifically Section 10.4.1-Substances. As outlined in this guidance, manufacturers are to reduce risk posed by substances or particles that may be released from a device; however, what does this really mean in practice, and how might sponsors adequately reduce risk?
Provided throughout this webinar will be guidance and answers provided for these common questions:
- What information can I expect and use from my material vendors?
- How does ISO 10993 address this and is it simply enough?
- What types of testing might be necessary, and more importantly, how do I decide if I need to conduct testing?