--- title: "ISO 11607 & EU MDR: Getting Clarity on Risk Management" description: The new clause in the EU MDR stating medical device development activities should “consider risk management to medical devices” is called into question. image: https://www.oliverhcp.com/hubfs/01%20Blog%20Thumbs/4-29-2020_MDR-1.png --- [Skip to Main Content](https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management#main-content) Language ![](https://www.oliverhcp.com/hubfs/down_arrow.svg) English ESPAÑOL DEUTSCH FRANÇAIS 日本語 한국어 中文 - [PackTalk ](https://www.oliverhcp.com/packtalk/) - [ISO Certifications & Product Documents ](https://www.oliverhcp.com/iso-certifications-and-product-documents) [![Oliver_Logo_4clr_RGB_NoTag 1](https://www.oliverhcp.com/hubfs/Oliver_Logo_4clr_RGB_NoTag%201.svg "Oliver_Logo_4clr_RGB_NoTag 1")](https://oliverhcp.com) Toggle Menu Search Site Search Site Search [ Contact Us ](https://www.oliverhcp.com/contact) Phone Close **Website Settings** - No Animations [![](https://www.oliverhcp.com/hubfs/Oliver-logo-half.svg) ](https://www.oliverhcp.com/) [![](https://www.oliverhcp.com/hubfs/phone.svg) 833.465.4837](tel:833.465.4837) Language ![](https://www.oliverhcp.com/hubfs/down_arrow.svg) ENGLISH 中文 ESPAÑOL DEUTSCH FRANÇAIS 日本語 한국어 [PackTalk](https://www.oliverhcp.com/packtalk/) SEARCH![](https://www.oliverhcp.com/hubfs/icon-search.svg) #### Expanded Stock Pouch Program ![](https://www.oliverhcp.com/hubfs/43.png) Expedited shipping from a partner you trust, now with more pouch options in a variety of sizes and materials. 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[Learn More](https://www.oliverhcp.com/stockpouchprogram) [![logo-pack-talk-2](https://www.oliverhcp.com/hubfs/logo-pack-talk-2.svg) ](https://www.oliverhcp.com/packtalk/) # ISO 11607 & EU MDR: Getting Clarity on Risk Management Oliver Healthcare Packaging Published on: 04/29/2020 Share:  [![](https://www.oliverhcp.com/hubfs/LinkedIn%20Icon.svg)](https://www.linkedin.com/sharing/share-offsite/?url=https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) [![](https://www.oliverhcp.com/hubfs/FB%20Icon.svg)](https://www.facebook.com/sharer/sharer.php?u=https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) [![](https://www.oliverhcp.com/hubfs/Email%20Icon.svg)](mailto:?subject=I%20wanted%20to%20share%20this%20great%20article&body=The%20article%20I%20wanted%20to%20share%20-%20https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works. It’s not news that review of ISO standards for medical device development is perpetual.  Not only does this keep the folks at ISO busy, it keeps those of us adhering to the standards on our toes, too. For the last year, there has been plenty of discussion of changes to [ISO 11607 Parts 1 and 2](https://www.oliverhcp.com/expertise/design-and-testing). The final implementation of the EU MDR this year was a key impetus behind the February 2019 ISO 11607-1/2 update. What has evolved since the release of the update, however, is further scrutiny. Specifically, regulators considered the broad direction of ISO 11607-2: 4.2. The new, brief clause simply states that medical device development activities should “*consider risk management to medical devices.*” The lack of detail and room for interpretation has been called into question. Ultimately, agreeing some definition was needed, the amending team has embarked on a refinement process. ![4-29-2020_MDR-1](https://www.oliverhcp.com/hubfs/01%20Blog%20Thumbs/4-29-2020_MDR-1.png?quality=low) [Full Article on ISO 11607-2 Risk Management](https://www.mddionline.com/update-iso-11607-and-eu-mdr) Share:  [![](https://www.oliverhcp.com/hubfs/LinkedIn%20Icon.svg)](https://www.linkedin.com/sharing/share-offsite/?url=https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) [![](https://www.oliverhcp.com/hubfs/FB%20Icon.svg)](https://www.facebook.com/sharer/sharer.php?u=https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) [![](https://www.oliverhcp.com/hubfs/Email%20Icon.svg)](mailto:?subject=I%20wanted%20to%20share%20this%20great%20article&body=The%20article%20I%20wanted%20to%20share%20-%20https://www.oliverhcp.com/news-and-resources/packtalk/iso-11607-eu-mdr-getting-clarity-on-risk-management) ## Stay up to date with PackTalk! 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