Clinical evaluation reports are a microcosm of the technical documentation package. It has the clinical evidence that your device meets the claims made but it is more than just that. It sends threads to every part of your technical file, linking preclinical evidence, risk assessments and sometimes even design requirements to clinical evidence. Knowing how to link these items together as guided by the 1000 + pages of MDCG guidance on clinical evaluation while meeting the requirements of Article 61 and Annex 14 can be a challenging road. We will set the guideposts.
Learning Objectives:
Identify the minimum bullets points or topics which need to be present in a clinical evaluation package.
Create a roadmap for your own clinical evaluation plan and report that a notified body can follow to see the evidence for your device and the claims you have made.
Determine that you have enough evidence to support your device and its performance and safety objectives.
