Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on SaMD under new EU MDR. SaMD manufacturers will benefit from clarifications on qualification and classification changes and action items to demonstrate compliance toward new regulation.
- The broadened definition of medical device under MDR is to start include devices with prediction and prognosis functionalities. Please be aware that under MEDDEV 2.1/6, SaMD with prediction and prognosis functionality have already been cited as qualification examples.
- Rule 11 under MDR applies to all software, not just SaMD. Rule 22 also affect some software products that combine diagnostic and therapeutic functions for Class III designation.
- Class I device manufacturer does not require QMS under MDD.
Please contact us if you have any questions!