We have a significant design change in the device which is certified as Class I device self declared under MDR regulation. I am going through the directive and I do not see any indication of process for Class I self declared device. My assumption is we need to notify the Authorized representative about the change and member state since notified body is not involved and keep the technical documentation relevant to new design. Please need advice on this.
Self Certified Class 1 MDR 2017/745 Design Change
- Thread starter Pavana
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