EU MDR General Safety and Performance Requirements (GSPRs)
General Safety and Performance Requirements (GSPRs) are a comprehensive set of criteria medical devices entering the EU market must meet. Outlined in EU MDR, they form the cornerstone of medical device regulatory compliance. GSPRs aim to ensure safety, performance,...
Class I Reusable Medical Devices: Class Ir under EU MDR
Class I reusable medical devices (Class Ir) refer to a subclass of Class I medical devices under the EU Medical Device Regulation. They cover reusable surgical instruments. Class Ir are non-invasive tools intended for repeated use in surgical procedures. They require...
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...