Under ISO 10993-1 and MDR, regulators will require detailed chemical information to support the direction of biocompatibility test plans.

If unknown chemicals are listed in a chemistry report, be prepared for regulators to ask you to go back and complete the identification—a complete characterization of your materials cannot happen with “unknowns.”

For risk-assessment approach best practices and guidance on how to handle chemistry report unknowns, read “Unknowns are Unacceptable.”