The European Union Medical Device Regulations (MDR) require manufacturers of medical devices to justify the use of substances classified as having Category 1A or 1B carcinogenic, mutagenic, or reproductive toxicity (CMR) at concentrations above 0.1 percent weight for weight (w/w). Often, these classifications are based on toxicity tests conducted with materials that are inherently different from the materials used in medical devices. Therefore, it is crucial that companies understand the toxicity associated with the material used in medical devices and consider weight of evidence approaches when preparing justifications for the use of CMR-classified substances. The goal of this session is to introduce attendees to the concept of utilizing appropriate data to justify the necessity of CMR classified substances while providing evidence of patient safety. Specifically, this presentation will discuss how various lines of evidence can be combined to justify substances' uses. The speaker will outline the use of several lines of evidence, including extractable and leachable data, toxicology testing of the device, and clinical evidence.
0.5 Contact Hours
Sharlee Lyn More