Prisma Project – Biological Evaluation, Sterilisation Validation, Validation of the Reprocessing of a Reusable Surgical Instrument

The purpose of this contract is to carry out laboratory testing and evaluation activities to support the manufacturer's technical documentation required under Regulation (EU) 2017/745 (MDR) for the device. ClearCut is classified as a Class I (Class Ir) reusable surgical instrument in accordance with Regulation 6 of Annex VIII of the MDR. This is a non-active device, for invasive surgical use, intended for temporary use and reused after cleaning, disinfection if necessary, and sterilization. ClearCut is a Class I orthopedic manual surgical instrument as defined in 21 CFR 888.4540. This is a non-motorized surgical guide used with an oscillating saw in orthopedic surgery. The device is Class I and exempt from premarket notification, but this exemption is subject to the restrictions in 21 CFR section 888.9. The scope includes: • validation of the claimed moist heat sterilization method, in accordance with EN ISO 17665:2024; • validation of instructions for cleaning, disinfection where applicable, and repeated reprocessing, in accordance with EN ISO 17664-1:2021, throughout the declared lifespan of the device, including verification of the integrity, safety and functional performance of the device after the maximum declared number of reuse cycles; • a biological assessment and, where the documented biological risk assessment identifies gaps, additional chemical, toxicological and/or biological tests, in accordance with standard EN ISO 10993-1:2025. • disinfection, if necessary The possibility of using the results of the project to support a regulatory file intended for the American FDA, if necessary, constitutes an appreciated asset with regard to the award criteria, but does not constitute a condition of eligibility. Said contract right tot