Regulatory and clinical professionals involved in the writing of Clinical Evaluation are already aware that the Medical Device Regulation 2017/745 brought additional expectations on the required content and level of clinical evidence required. Since then, MDCG documents have further clarified the expectations on manufacturers. In this session, we will explore the following part of the MDR, Annex XIV, Part A, section 1;
“an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device”
This session will discuss what is expected from manufacturers for these Quantifiable Specifications, which are to be justified from the state-of-the-art in medicine and used to judge the acceptability of the evidence collected towards the demonstration of the benefit-risk ratio for the device under evaluation.
The session will present examples of appropriate Safety and Performance Specifications, including the use of appropriate evidence sources from the state-of-the-art to adequately justify the quantitative thresholds defined for each Specification. Using case studies from real-world examples, the session aims to stimulate discussions on how to derive such Quantifiable Specifications, also considering the type of clinical evidence coming from PMCF activities on the device under evaluation, and the considerations to ensure the clinical endpoints used in PMCF studies can be aligned with the Quantifiable Specifications derived from the state-of-the-art in medicine.
Learning Objectives:
Upon completion, particpants will appreciate how to derive meaningful specifications which shall be used to measure the safety and performance of a given medical device
Upon completion, particpants will appreciate how to set acceptance criteria to these defined specifications, and how to leverage suitable sources to justify the thresholds set.
Upon completion, particpants will appreciate the considerations on how to align evidence coming from PMCF activities with the derived Quantifiable Specifications.