--- title: Required Steps for CE Marking MDR and IVDR Devices - Whitepaper description: There’s no getting around it – if you want to sell medical devices in the European Union, you need a “Conformité Européenne” (CE) mark. It’s your declaration that your device complies with the requirements of all relevant European Medical Device Regulations and/or Directives, especially the new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR).   image: https://info.argosmultilingual.com/hubfs/Multilingual%20Pay%20Per%20Click%20(PPC)%20for%20Localization%20Managers-1.png --- [Skip to the main content.](https://info.argosmultilingual.com/required-steps-for-ce-marking-mdr-and-ivdr-devices-whitepaper#main-content) [![icon-white 2025](https://info.argosmultilingual.com/hs-fs/hubfs/2025%20Logos/icon-white%202025.png?width=216&height=201&name=icon-white%202025.png "icon-white 2025")](https://www.argosmultilingual.com/) [![icon-blue 2025](https://info.argosmultilingual.com/hs-fs/hubfs/2025%20Logos/icon-blue%202025.png?width=216&height=201&name=icon-blue%202025.png "icon-blue 2025")](https://www.argosmultilingual.com/) - [Solutions](https://www.argosmultilingual.com/) - [About Us](https://www.argosmultilingual.com/about-us) - [Resources](https://www.argosmultilingual.com/resources) - [Blog](https://www.argosmultilingual.com/blog) - [Contact Us](https://www.argosmultilingual.com/contact-us) Toggle Menu Toggle Menu - [Solutions](https://www.argosmultilingual.com/) - [About Us](https://www.argosmultilingual.com/about-us) - [Resources](https://www.argosmultilingual.com/resources) - [Blog](https://www.argosmultilingual.com/blog) - [Contact Us](https://www.argosmultilingual.com/contact-us) **-Whitepaper-** # Required Steps for CE Marking MDR and IVDR Devices Take the mystery out of applying for a CE mark    There’s no getting around it – if you want to sell medical devices in the European Union, you need a “Conformité Européenne” (CE) mark. It’s your declaration that your device complies with the requirements of all relevant European Medical Device Regulations and/or Directives, especially the new **Medical Devices Regulation (2017/745/ EU) (MDR)** and the **In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR)**.   As with any bureaucratic process, the road to certification can be long, complicated, and confusing – even knowing where to begin can be a challenge. Fortunately, we’ve put together a whitepaper that lays out exactly what you need to do, when you need to do it, and who you should consult if complications arise.  Download the whitepaper here and get your journey to conformity started on the right foot.  ![Required Steps for CE Marking MDR and IVDR Devices cover](https://info.argosmultilingual.com/hs-fs/hubfs/Required%20Steps%20for%20CE%20Marking%20MDR%20and%20IVDR%20Devices%20cover.png?width=350&height=431&name=Required%20Steps%20for%20CE%20Marking%20MDR%20and%20IVDR%20Devices%20cover.png) [![Download Now](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/26728782/c1048f54-c57c-4872-8127-8c5718b2f276.png)](https://hubspot-cta-redirect-eu1-prod.s3.amazonaws.com/cta/redirect/26728782/c1048f54-c57c-4872-8127-8c5718b2f276) --- ## Subscribe to the Argos Newsletter   Stay in the know with all things translation with our ad-free newsletter. Every other week, no spam. 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