1. Understanding the Term “Legacy Devices” Under EU MDR Definition of Legacy Devices under EU MDR Under the European Union Medical Device Regulation (EU MDR 2017/745), “legacy devices” refer to medical devices that were lawfully placed on the market under the previous regulatory frameworks—the Medical Device Directive (MDD 93/42/EEC) or the Active Implantable Medical Devices […]
1. Definition & Regulatory Context Definition of Custom-Made Devices (CMDs) Under Article 2(3) of the EU MDR, a custom-made device is defined as any medical device specifically made in accordance with a written prescription provided by a qualified medical professional, indicating the design characteristics and intended use of the device, and intended solely for the
1. Introduction: What is SaMD? Definition of SaMD Software as a Medical Device (SaMD) refers to software that is intended to perform medical functions without being part of a hardware medical device. It operates independently of any physical device, meaning it does not require embedded systems in medical hardware to serve its purpose. SaMD may
Background: Why PMS & PMCF are Game-Changers under EU MDR Regulatory Evolution: From MDD to MDR Under the previous Medical Device Directive (MDD 93/42/EEC), Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) were vaguely defined and often implemented passively. Manufacturers generally conducted PMS reactively—primarily investigating complaints or adverse events without a proactive approach to data
Background Context The EU Medical Device Regulation (MDR 2017/745) came into force in May 2021 (with transition timelines extended to 2028/2029 in some cases via Regulation (EU) 2023/607). It introduced stricter requirements for clinical evidence, post-market surveillance, quality management, traceability, and technical documentation compared to the previous Medical Device Directive (MDD 93/42/EEC). For Small and