MDR 2017/745

Key Components of a Successful Clinical Evaluation Report under MDR 2017/745 A Clinical Evaluation Report (CER) becomes an essential document in terms of safety and performance of the device to prove that a device is safe and performs as intended. These are the key components of a successful CER within the framework of MDR 2017/745. Scope and Objectives The first and foremost stage in the preparation of the Clinical evaluation report includes and emphasizes the clear definition of its respective scope and objectives. Aspects of this include defining the description of the device, of its intended purpose. This must include risk classification [...]