Exclusion Testing for Material Compliance Regulations of Medical Device Components has multiple regulating bodies (MDR, REACH, RoHS, the State of California). These regulating bodies 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.