---
title: Implementing Changes to SaMD under new EU MDR - Rook Quality Systems
description: Implementing Changes to SaMD under new EU MDR Rook Quality Systems Click here to learn more!
---

[Blog - Rook Quality Systems ](https://rookqs.com/blog)

# [Implementing Changes to SaMD under new EU MDR - Rook Quality Systems](https://rookqs.com/blog/podcast-implementing-changes-to-samd-under-new-eu-mdr)

 Written by [Andrew Wu](https://rookqs.com/blog/author/andrew-wu) | Oct 11, 2020 12:06:44 PM

[LISTEN NOW](https://www.greenlight.guru/blog/samd-changes-eu-mdr)

Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on [SaMD](https://rookqs.com/solutions/samd-support/) under new [EU MDR](https://rookqs.com/product/mdr-templates/). SaMD manufacturers will benefit from clarifications on qualification and classification changes and action items to demonstrate compliance toward new regulation.

Podcast takeaways:

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 if you have any questions!

[SCHEDULE CONSULT](https://rookqs.com/contact/)

**Sponsored by **

[View full post](https://rookqs.com/blog/podcast-implementing-changes-to-samd-under-new-eu-mdr)

```json
{
  "@context" : "http://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Andrew Wu"
  },
  "dateModified" : "2024-12-17T15:49:44.708Z",
  "datePublished" : "2020-10-11T12:06:44Z",
  "headline" : "Implementing Changes to SaMD under new EU MDR",
  "image" : {
    "@type" : "ImageObject",
    "height" : 60,
    "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
    "width" : 60
  },
  "mainEntityOfPage" : "https://rookqs.com/blog/podcast-implementing-changes-to-samd-under-new-eu-mdr",
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "height" : 60,
      "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
      "width" : 60
    },
    "name" : "Blog - Rook Quality Systems"
  }
}
```