Are you ready for the EU ivdr?

The In Vitro Diagnostic Regulation (IVDR) is now in effect. Ensure your organization remains compliant with the latest standards.

 

2017-2025

May 26, 2017

EU IVDR published and entered into force

Nov 26, 2017

Notified bodies may apply for designation according to the EU MDR

Nov 26, 2017

May 26, 2022

EUAMED goes live

May 26, 2022

IVDR Date of Application. EC Certificate of Conformity issued before May 26, 2017 will expire. Certificates issued under the IVDD after May 26, 2017 are valid for an additional 2 years

May 26, 2022

May 26, 2024

All devices placed on the market must conform with IVDR. EC Certificates issued after May 26, 2017 become void

May 26, 2025

All devices with IVDD certificates can no longer be sold or put into service

May 26, 2025

We can help you translate your content to stay compliant

 

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EU IVDR

Translation & Content Strategy

An insightful guide that looks at the European Union's In Vitro Diagnostic Regulation (IVDR) through the lens of translation and content strategy. 

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EU IVDR Translations

What You Need to Know

As a localization manager, you may be wondering what the IVDR means for translation and what types of content you should prepare your team for.

MDR & IVDR - The Path to Compliance

EU MDR & EU IVDR

The Path to Compliance

While it can feel overwhelming to know how to get started with MDR and IVDR, these nine high-level steps can help you get on the right path to complying with these regulations.

MDR - IVDR Checklist - Argos Multilingual

EU MDR & IVDR Checklist

For Translation

With all the things your company is doing to get ready for MDR and IVDR, it’s easy for translation-related items to fall through the cracks. Give yourself additional peace of mind by making sure you’ve checked every box!

Use This Time Wisely: Seven Proactive Steps to Take Now for EU MDR and IVDR Compliance

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Working Effectively with Notified Bodies

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6 Ways a Centralized Translation Model Can Support Your MDR and IVDR Compliance

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Understanding EUDAMED: Its Role in EU Medical Device Regulation

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What Is the European Free Trade Association (EFTA) and How Does It Affect MDR + IVDR?

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Stop the Clock: Revised IVDR Deadlines Offer MDMs a Timely Advantage

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How have the EU MDR and IVDR Changed Clinical Investigations?

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Why is Localization Essential for Regulatory Compliance?

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How Multilingual Life Sciences Marketing Unlocks Global Markets

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GET IN TOUCH

To learn how Argos Multilingual can guide you and your business through the EU IVDR directive and its requirements, please get in touch with us by filling in the form.