CLINICAL EVALUATION UNDER THE EU MDR 2017/745 – 24.09.2021 and upon request

The Medical Device Regulation EU MDR 2017/745 introduced higher requirements for clinical data and the clinical evaluation process. To ensure that you are fulfilling the requirements on the road to MDR, we are offering detailed insight about the requirements, their backgrounds and links to risk management, post-market surveillance (PMS), post market clinical follow-up (PMCF) and MDR as well as the best way to show compliance. This training provides you with insight on the various stakeholder interactions within the evaluation process, the importance of the state-of-the-art establishment, identification and appraisal of pertinent data while giving you the needed methodologies for the clinical evaluation report.

• Opening remarks
• What can influence and drive the clinical evaluation and vice versa?
• Which information is necessary to start the clinical evaluation?
• What are the differences and requirements of the clinical development plan (CDP) and clinical evaluation plan (CEP)?
• Structure and content of the clinical evaluation report (CER)
• Device description requirements
• Establishment of the state-of-the-art
• Identification and appraisal of pertinent data (literature search report
• Requirements for the analysis of clinical data including legacy devices
• Requirements for the analysis of performance and safety claims of the device
• Requirements for PMS/PMCF activities throughout the expected lifetime of the device
• Establishment of the benefit/risk ratio
• Q&A session
• Closing remarks

• Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided.