Reprocessing Validation
MDR Reference: Annex I, GSPR 11.7; Annex II, Section 6
Service Item ID: mdr_sec06_reprocessing
Applicability: Reusable medical devices requiring cleaning, disinfection, and/or sterilisation between uses
Overview
Reprocessing validation demonstrates that reusable devices can be safely and effectively cleaned, disinfected, and/or sterilised according to the manufacturer's IFU without adverse effects on device safety and performance. The primary standard is ISO 17664.
Key Standard: ISO 17664
ISO 17664-1:2017 (reusable medical devices) and ISO 17664-2:2021 (single-use devices reprocessed by third parties -- informative):
- Defines information to be provided by the manufacturer for reprocessing
- Covers cleaning, disinfection, drying, inspection, packaging, sterilisation
- Requires validation of the entire reprocessing cycle
Key Deliverables
| Document | Description |
|---|---|
| Reprocessing IFU | Validated cleaning/disinfection/sterilisation instructions |
| Cleaning Validation | Soil removal, residual protein/bioburden testing |
| Disinfection Validation | Microbial reduction demonstration |
| Sterilisation Validation | SAL achievement post-reprocessing |
| Reprocessing Cycle Limit | Maximum number of reprocessing cycles with supporting data |
| Functional Performance after Reprocessing | Device performance at end of reprocessing life |
| Residual Contamination Limits | Acceptable levels after cleaning |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 11.7 | Reusable devices: reprocessing validated |
| 23.4(k) | IFU to include reprocessing instructions |
Related Topics
- Sterilisation Validation -- Terminal sterilisation after reprocessing
- Biocompatibility -- Reprocessing agents may affect biocompatibility
- Device Lifetime Validation -- Reprocessing cycle count as lifetime parameter