EU MDR UDI Requirements: Everything You Need to Know
Under the EU Medical Device Regulation (MDR), the Unique Device Identification (UDI) system is mandatory for most medical devices. The aim is to enhance traceability, post-market surveillance, and patient safety. Manufacturers must assign a Basic UDI-DI for device...
Mandatory QMS for all Classes of Medical Devices per EU MDR
Quality management system (QMS) is a structured framework that ensures an organization consistently delivers products meeting customer and regulatory requirements. Notably, EU Medical Device Regulation (MDR) has specified mandatory QMS for all classes of medical...
10 Key Roles and Responsibilities of EU MDR Notified Body
An EU MDR notified body is an independent organization designated by an EU Member State. Notified Bodies play a central role in EU MDR compliance. They independently assess whether medium- and high-risk medical devices meet EU MDR requirements before they can be...