Here, you will find helpful information on different regulatory affairs related topics in the medical device field.
EUDAMED has updated the user guide UDI Devices – Production v 2.11. Here are some of the main topics: Basic UDI-DI Identification Details:The guide provides instructions on how to fill in the Basic UDI-DI identification details. EUDAMED will validate the Basic UDI-DI code based on......
What is MDCG? The MDCG ensures that regulatory authorities in the European Union member states have a forum for coordinating their efforts and sharing best practices related to medical device regulations. This includes the implementation and application of the MDR and the IVDR. This group......
🌍 Stay Ahead in the Medical Device World! 🌍 Navigating the intricate landscape of EU medical device regulations can be challenging. Whether you’re delving into the nuances of MDR, IVDR, or exploring the frontier of AI in medical devices, we’ve got you covered. ✨ Why......
An In-Depth Guide for Manufacturers Post-market surveillance (PMS) is a critical regulatory requirement for medical devices and in vitro diagnostic devices within the European Union. The EU MDR 2017/745 and IVDR 2017/746 lay down specific guidelines for post-market surveillance to ensure ongoing safety, performance, and......
In the medical device industry, a Regulatory Affairs Job, such as a Regulatory Affairs Specialist or Regulatory Affairs Manager, plays a pivotal role in guiding a medical device from its development phase to its sale in the market. These Regulatory Affairs professionals ensure that medical......