Multiple regulating bodies (MDR, REACH, RoHS, the State of California) have prepared lists of harmful or potentially harmful compounds that are to be excluded from various commercial products. Specifically, MDR guidelines require collection of data and documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances.
Companies who import products into Europe are required to disclose the materials of construction to various regulating bodies. Often, manufacturers rely on their material and component suppliers for this information. However, in many cases, suppliers are either not forthcoming with this information or a manufacturer might want to confirm the supplier’s information. Therefore, the manufacturer needs to perform analytical testing to demonstrate the absence of excluded compounds.
EAG has compiled a master list of more than 4,000 excluded compounds. We have assessed each of the compounds present from a scientific standpoint to address the likelihood of each compound being used in a medical device. This drastically reduces the number of compounds that need to be screened. EAG scientists perform screening for the remaining compounds using several different analytical methods including:
EAG is your partner in meeting pertinent regulatory guidelines. We can customize an approach to meet your specific needs:
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