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Since our founding in 1997, we have been at the forefront of applying advanced technology to deliver the highest quality translations quickly, efficiently and at scale. Through constant investment in these technologies and our early adoption of AI, Welocalize has earned a reputation for delivering innovative solutions.

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IVDR Compliance – Precision, Accuracy & Regulatory Confidence

The In Vitro Diagnostic Regulation (IVDR) is reshaping the landscape for medical device manufacturers, requiring higher transparency, stricter labeling regulations, and precise multilingual documentation. Non-compliance isn’t an option

Bring Your Diagnostic Products to Market. With Confidence.

Welocalize ensures your IVD devices meet EU IVDR requirements with accurate, compliant, and culturally adapted translations. With our AI-driven linguistic validation, regulatory expertise, and scalable multilingual solutions, you can bring your diagnostic products to market with confidence.

What Is IVDR? Why Does It Matter?

The EU In Vitro Diagnostic Regulation (IVDR 2017/746) replaces IVDD, introducing stricter requirements for:
Multilingual labeling & IFUs (Instructions for Use)
Increased scrutiny of diagnostic claims
UDI (Unique Device Identification) compliance
Post-market surveillance & traceability

By May 2025, all IVD devices in the EU must fully comply. Are you ready?

Ensure Global Compliance with IVDR

Achieve compliance across international markets with our end-to-end services—built to help you adapt to evolving regulations while maintaining full control and visibility over your content.