Table of Contents
Class I reusable compliance to EU MDR: Introduction
We should all by now know that class I reusable device is a new category introduced by EU MDR. (click here to get a copy of EU MDR). Previously under MDD, for class I devices, only sterile and device with a measuring function needs a Notified Body (NB) intervention to attain CE Marking (as CE certification is needed). The NB would focus the audit on aspects which are related to sterility and accuracy of measurement. The NB would for example scrutinize the sterilization validation or calibration report of the device/s. The same would go for class I reusable devices. Below are some of the items that NB would focus on:
Class I reusable compliance to EU MDR: Points to focus for NB audit
- Instruction for use – contents related to reprocessing including number of times the device can be used before replacement
- Instruction for use – details for reprocessing (autoclave parameters or disinfecting agents to be utilised
- Reprocessing validation
- Performance validation (lifetime of the product)
- Biocompatibility assessment with consideration to lifetime and after reprocessing process
- Risk assessment (focus on hazards related to reprocessing
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