MDR Clinical Evaluation Plan Template | Best CER Documentation Clinical Evaluation Plan. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies, discuss its phases, and evaluate the associated legislative and risk aspects. Again, this will serve. There are two main things to consider when creating a Design and Development Plan for a medical device. GlobalData's Medical Devices sector report, "Capsule Endoscopes - Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the Capsule Endoscopes pipeline products with comparative . The European Commission's Medical Device Coordination Group (MDCG) has published a Q&A reference document covering clinical investigation requirements under the Medical Devices Regulation (MDR). The design and development process - Qserve® Group Adequate and well-controlled clinical studies. The requirement for clinical evaluation of medical devices was originally set out by EU legislation in the . Sleep Apnea Diagnostic Systems - Medical Devices Pipeline Assessment, 2020 They must also align with the clinical evaluation plan. Clinical Development Plan Template (Project).tat (OnePager Template) Microsoft Project Instructions To build a clinical trial milestone timeline like the example above, follow these instructions: Download the two sample files listed above. intended purpose or purposes of the device - Clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies . This blog may aid in understanding and provide guidance on the first step of providing clinical evidence: writing a Clinical Evaluation Plan (CEP). Some manufacturers may need more clarity, though, in order to meet CDP requirements as part of their broader MDR compliance efforts. Protocol Templates for Clinical Trials | grants.nih.gov Technical Documentation for the Medical Device Regulation (MDR) In Vitro Diagnostic . Clinical trials: Medical device and drug development