Post-Market Surveillance (PMS): Ensuring Compliance Across the EU, UK, and Switzerland Requirements
Executive Summary PMS is a regulatory requirement that systematically monitors a medical device's safety, performance, and quality once it enters the market. PMS processes allow manufacturers to collect real-world data, assess device efficacy, and ensure long-term compliance with regulatory standards. QNET, as your Authorized representative in the EU, UK, and Switzerland, has an important role in informing manufacturers to meet PMS requirements. 2. PMS Requirements by Region European Union (EU) The EU's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 mandate that manufacturers implement a PMS system that integrates with their Quality Management System (QMS). Essential…
