Reusable medical device reprocessing validation
To comply with the requirements of the Medical Devices Regulation (MDR) 2017/745, re-processable medical device manufacturers must provide reprocessing instructions describing cleaning, disinfection and sterilization and prove that these procedures are valid. Medical device manufacturers must also demonstrate the safety of the product after reprocessing and over the entire product life cycle.
Test Labs IFU validation method is based on ISO 17664-1 and ISO 17664-2. Service offer includes the evaluation of the effectiveness of your cleaning, disinfecting and sterilization instructions; selection of the most appropriate test soil or organism to simulate relevant clinical use and identification of inoculation sites on your instruments. We will support you in the optimization of your Instruction for Use. Test methods include:
The classification of medical devices is governed by the intended purpose of the device and their inherent risks linked to duration, part of the body, whether it is active or not and whether it is invasive or non-invasive. Based on the classification rules outlined in Annex VII, manufacturers should determine which class their medical device falls under; Class I, Class IIa, Class IIb, or Class III. If more than one rule applies, then the highest classification should apply.
Under the MDR some Class I medical devices have now been reclassified, and the classification has been broken down into include Class Im, Class Is and Class Ir meaning present guidelines cannot be applied to devices now in a higher risk class. Manufacturers with devices which are intended to be used in a sterile condition (Class Is), with a measuring function (Class Im) or are reusable surgical instruments (Class Ir), must now apply the procedures set out in Annex IX and have involvement from a notified body. Learn more