Reprocessing Medical Device FDA / MDR Readiness
Validated Reprocessing for Patient Safety and Compliance
Processing / Reprocessing of medical devices is essential to ensure that reusable instruments are free from contamination before each use, eliminating any risk of infection for patients. Regulations and standards such as the EU Medical Device Regulation (MDR 2017/745), ISO 17664, FDA’s Reprocessing of Reusable Medical Devices guidance as well as ANSI/AAMI ST98 require manufacturers to provide a validated processing / reprocessing procedure, ensuring patient safety and full compliance.
Our services include:
FDA Readiness:
✓ Reprocessing Validation (ISO 17664)
Efficiency control of cleaning (ANSI / AAMI ST98)
→ 6 Simulated Use cycles incl. visual evaluation of residual moisture after cleaning + disinfection
Efficiency control disinfection (AAMI TIR 12)
Efficiency control sterilization (ISO 17665), incl. visual evaluation of residual moisture → incl. visual evaluation of residual moisture
Optional: Preparatory cleaning/sterilization to remove production residues / residues from transport
✓ Rinsing Validation (after 1 cycle of complete reprocessing)
- Preparatory cleaning / disinfection / sterilization
- Optional: Cytotoxicity test
- TAT*: 11-17 weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
MDR Readiness:
✓ Reprocessing Validation (ISO 17664)
Efficiency control of cleaning & disinfection
→ Can be validated at the same time, microbiological method
Efficiency control sterilization (ISO 17665)
Optional: Preparatory cleaning/sterilization to remove production residues / residues from transport
✓ Non-detraction of biocompatibility (after 1 cycle of complete reprocessing)
- Preparatory cleaning / disinfection / sterilization
- Optional: Cytotoxicity test
- TAT*: 9-15 weeks
✓ „End of Life “-Testing (Non-detraction of biocompatibility, functionality, reprocessability)
Repeated processing (performance in blocks of 10 cycles)
Optional: Cytotoxicity test
Optional: Chemical analysis
Optional: Processing / Reprocessing validation
🡪depending on the specific product
- TAT*: 2-3 Weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
