Reusable Surgical Instruments (Class Ir)
Overview
Class Ir devices are reusable surgical instruments — instruments intended for surgical use by cutting, drilling, sawing, scraping, clamping, retracting, clipping, or similar procedures and intended to be reused after appropriate procedures have been carried out. Class Ir requires NB involvement specifically for the reprocessing aspects of the conformity assessment.
Reprocessing Information Requirements
Manufacturers of reusable surgical instruments must provide validated reprocessing instructions. MedDO Annex I § 23.4(p) requires that the IFU includes all information needed for reprocessing, including:
- Type and method of cleaning, disinfection, and sterilisation
- Cycle parameters validated by the manufacturer
- Maximum number of reprocessing cycles
- Details of inspections required before reuse (damage indicators)
- Validated and standardised procedures (ISO 17664)
NB Involvement
The NB assesses the conformity of the reprocessing information and validation documentation. The NB certificate covers only the reprocessing aspects; the overall DoC remains the manufacturer's responsibility.
Official Sources
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