Clinical evaluation, PMS/PMCF - requirements for plans and reports requirements with impact on medical writing - Susanne Gerbl-Rieger
10:45 AM - 11:30 AM
The presentation focuses on the clinical evaluation process including different aspects of planning and reporting as specified in the EU Regulation for Medical Devices (MDR). Clinical evaluations, the associated plans and reports should be continuously updated throughout the entire lifecycle of medical devices. This leads to huge amount of and demand for high quality and scientifically valid documentation. To achieve the required systematic and objective approach, clinical evaluation must be based on procedures and documents such as
• clinical investigation plans (CIP) and reports (CIR)
• clinical evaluation plans (CEP) and reports (CER)
• post market surveillance (PMS) and post market clinical follow up (PMCF) plans and reports
• summaries of safety and clinical performance (SSCP)
• periodic safety update reports (PSUR).
The plans should define the type of clinical data and the methods that are appropriate to identify, collect, appraise and analyse clinical data in the pre- and postmarket phases. Furthermore, these define the type of reports and summaries on safety or performance to be developed or updated at pre-defined intervals. The outcomes of all planned activities need to
• result in sufficient clinical evidence
• demonstrate and confirm compliance with general safety and performance requirements
• demonstrate acceptability of benefit /risk ratio
• identify new emerging risk when using the device according to the manufacturer´s instructions
• identify potential device misuse.
Each clinical claim must be substantiated with clinical evidence. CERs and related reports should be suitable to demonstrate that the device reflects state of the art when used as intended. Clinical evaluation reports for class III implantable and certain active class II devices will require utmost high quality and scientific validity as these will be submitted for consultation to an expert panel of the European Commission. It is therefore mandatory that medical writers developing these documents are aware of and qualified to follow the challenging requirements of the MDR for the documentation linked to clinical evaluation, PMS and PMCF.