Introduction EU Regulation 2017/746 (IVDR) is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union. It was published in April ’17 and is closely aligned to the EU regulation on medical devices. The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate … Learn More
Introduction In January 2024 the European Commission decided to delay some elements of IVDR. But, to protect patient care and safety they at the same time agreed to speed up the launch of some parts of the European Database on Medical Devices (EUDAMED). What Is EUDAMED EUDAMED is the IT system established by IVDR, and … Learn More
Introduction In a recent blog post titled Complying with European In-Vitro Diagnostic Regulation (IVDR) Language Translation Requirements, we described what this is regulation is and its intent. In summarizing, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold. When enacted … Learn More
Introduction EU Regulation 2017/746 is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union. It was published in April ’17 and is closely aligned to the EU regulation on medical devices. The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate clinical … Learn More