MD&M West 2021 Tech Talk presentation

Eric Uffman, Sales director, EAG Laboratories presented Chemical Characterization for MDR Compliance calls at MD&M West 2021 Tech Talk. On May 26^th of this year, the new Medical Device Regulation (“MDR”) went into effect for devices marketed in Europe. This regulation calls out over 1,000 substances that are “carcinogenic, mutagenic or toxic to reproduction (‘CMR’)” and requires that these substances cannot be present at more than 0.1% (by wt.) in a medical device. EAG has developed an evaluation program that combines a systematic review of material data and application use along with chemical screening and evaluation against the MDR standard.  We will discuss this time and money saving approach and how this testing compares with ISO 10993-18 testing.