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Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.
Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well once the regulation comes into force. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully.
If you have existing CERs, you need to develop an action plan to identify and address the gaps.
If you will be CE Marking a new device, you must ensure you have sufficient clinical data to show compliance with the essential requirements for safety and performance.
We will discuss the key changes and additional CER content required so that you can ensure your CERs are in compliance with MEDDEV Rev 4. Looking ahead to MDR enforcement, we will also discuss how the new regulations impact your CERs.
Finally, we'll look at the common mistakes manufacturers make and how to avoid them, suggestions from a Notified Body perspective, and case studies of the most common problems related to Rev 4.
During the session we will cover:
- The Clinical Evaluation Plan and why you need it
- The five stages of clinical evaluation
- New requirements for justifying equivalence to a competitive device
- Qualifications of the CER evaluators
- State of the art
When we're done, you'll leave with:
- Understanding the MEDDEV 2.7/1 revision
- Knowing how the revision impacts your CERs
- Understanding how to bring your CERs into compliance
- Knowing what changes the MDR will bring to CERs in the future