Introduction The European Union Medical Device Regulation (MDR) adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EMA and for national authorities in the assessment of certain categories of medical products. The aim of the MDR is to ensure patient safety and provide greater transparency and traceability … 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