© 2017 Rook Quality Systems. All Rights Reserved. 

[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems.

You will find this podcast helpful for understanding changes imposed on SaMD under new EU MDR. SaMD manufacturer will find this podcast helpful for clarifications on qualification and classification changes on SaMD, and action items to demonstrate compliance toward new regulation. 

 

Link to the Podcast: https://www.greenlight.guru/blog/samd-changes-eu-mdr

 

Issuance of clarifications for this podcast: 

1. 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. 

2. 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. 

3. Class I device manufacturer does not require QMS under MDD. 

 

Please contact us at info@rookqualitysystems.com if you have any questions. 

 

 

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