Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
In this presentation we discuss strategies for the verification of device safety and performance in the clinical evaluation. Our seasoned CER medical writers are rooted in MDR-compliant practices. Likewise, this presentation will help you identify meaningful safety and performance measures for the clinical evaluation. In addition, we will define parameters to determine the acceptability of benefit-risk. Afterwards, we will have about 10-15 minutes to answer any questions you may have on this topic.
Who should watch the recording?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve CERs for EU MDR submission. Anyone interested in learning more about MDR requirements for CERs is encouraged to come too. We encourage attendees from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
Watch the recording!
Clearly Defining Measurable Safety and Performance Endpoints
All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation.
newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations. Read more on this topic in our recent blog post, here.
Want to read the highlights to verifying your device’s safety and performance? Download our white paper where we give your the best approaches to finding measurables objectives and acceptance criteria for your medical device.