MDR (EU) 2017/745
Conformity assessment and certification under the European Medical Device Regulation for market access.
Learn MoreSurgical Instruments
Regulatory compliance and certification services for reusable and single-use surgical instruments under MDR (EU) 2017/745.
Certification for Surgical Instruments
Surgical instruments — whether reusable or single-use — must meet exacting standards for design, materials, performance, and sterility. Under MDR (EU) 2017/745, manufacturers of surgical instruments face specific requirements depending on their device classification, intended use, and whether the instruments are intended for reprocessing.
Udem Atlantic's certification services for surgical instrument manufacturers cover the full spectrum of regulatory requirements. Our assessors evaluate technical documentation including biocompatibility data, sterilization validation, reprocessing instructions for reusable devices, and usability testing in accordance with IEC 62366.
We provide ISO 13485 certification tailored to the manufacturing processes typical of surgical instrument production, including incoming material controls, process validation for finishing operations, and packaging validation. Our goal is to ensure that your quality management system meets both the letter and spirit of regulatory requirements while supporting efficient manufacturing operations.