The introduction of the MEDDEV 2.7/1 Rev. 4, in June 2016, is part of the significant changes happening across the medical device regulatory landscape.
This particular change is connected to introduction of the EU MDR enacted in 2017 and will significantly impact the procedures surrounding post-market clinical information, device equivalence, and clinical evidence at medical device companies. Although writing of Clinical Evaluation Reports was already a requirement for EU compliance, the previous revision of this MEDDEV didn’t provide much structure – neither to the manufacturer or to the Notified Body. As such, Clinical Evaluation Reports were relatively easily accepted. This has been changed.
The MEDDEV update made the Notified Bodies change their process, focusing on detail and now expecting a considerable effort from the manufacturer. What does this mean for manufacturers? They must gather more data, provide more analysis, and update their existing reports for all the devices in their portfolio, in an almost unworkable short amount of time…
In this workshop, Christine Zomorodian and Anne Leijsen will guide you through the development of process and the creation of the new clinical evaluations.
Christine is the ideal person to guide the process of designing a clinical evaluation structure in the context of your company. With the increased focus on post-market medical device data, Clinical Evaluations have become a focus of notified body review efforts. When should your clinical evaluations be performed? What information needs to be collected? And how do you ensure that there is a continuous process that allows evaluation of all your currently-marketed devices?
At the same time, Anne would be the best person to provide you all information you need for the creation of clinical evaluations. She has been working on numerous Clinical Evaluation Reports, submitted to and been accepted by several Notified Bodies. She will guide you through the exact requirements of the data gathering and writing processes: What are the steps that are to be taken? Where should you put the focus of the evaluation? What data shall be captured, and what shall be done if there is not much data available on your device? Who should be involved in the clinical evaluation process to get the best results? And what are the differences between clinical evaluations for different device classes?
If your work remotely touches this area, you should be in this workshop.
Christine Zomorodian
Anne Leijsen
