Understanding eIFU for Medical Devices under EU MDR and IVDR
SAY GOODBYE TO PAPER? UNDERSTANDING EIFU IN THE EU THE EASY WAY In the EU, every medical device must include clear Instructions for Use (IFU) to help users operate it safely. Traditionally, this information is provided on paper, but many manufacturers now prefer offering it digitally as an electronic IFU (eIFU) for example, through a […]
India’s BIS Accelerates Medical Device Standardization to Strengthen Patient Safety and Innovation
01 November 2025, India — The Bureau of Indian Standards (BIS), India’s National Standards Body, has announced a significant step toward strengthening the regulatory and quality framework for medical devices in India. In a press release issued on November 25, 2024. BIS Strengthens Patient Safety for Medical Devices, with Completion Targeted by December 2025.The Ministry […]