DRAJ

Understanding Clinical Evaluation Reports (CERs) in EU MDR Definition and Purpose of Clinical Evaluation Reports (CERs) A Clinical Evaluation Report (CER) is a critical technical document required under the European Union Medical Device Regulation (EU MDR 2017/745). It provides a structured presentation of clinical data to demonstrate that a medical device is safe, performs as […]

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 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