This session’s topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
Are you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session, our President Laurie Mitchell answers questions regarding how to identify meaningful safety and performance endpoints. In addition, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs. If you attended our hour-long webinar on August 25, but we did not answer your questions we encourage you to attend to get your questions answered on this topic.
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, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.