With the introduction of Regulation EU MDR 2017/745, reusable rigid endoscopes are now class I reusable medical devices (class I, reusable or class Ir).
Reusable rigid endoscopes deteriorate over time, so the legislator has now laid down stricter requirements for the conformity assessment procedure for these products.
For Class Ir products that are both reusable surgical instruments and have a measurement function, the effects of reprocessing on the measurement function must be evaluated and documented.
That means that hospitals, repair centres and reprocessing companies need to set up their own systems to be compliant.
Here are some important requirements:
- - Relevant information about inspection, calibration and testing during and/or after processing to ensure proper function and safe use
- - Prove the influence of multiple reprocessing has not had a negative impact on the quality of the product
- - Recognize when the reusable device is end of life by either:
- * adhere to the specified maximum number of reprocessing and provide appropriate evidence of this number
- * evidence of material wear or loss of product integrity
- * Consideration of the compatibility of the raw materials with the reprocessing processes (cleaning / disinfection / sterilization)
- - Direct labelling of reusable products, meaning that you need to print a label for each reusable product with relevant quality data