Part of your month, [almost*] every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: July 25th, where we'll discuss cybersecurity (*there will be no R&Q Intelligence Series webinar in June).
Please join us for a free R&Q Intelligence Series webinar:
MEDDEV 2.7/1 & CERs: Know the changes and what to do.
The session will be held on Tuesday, May 23rd from 1:00pm - 2:00pm EST. The learning opportunity is free.
Prepare for and meet the requirements.
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.
What will be covered?
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.
- 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 evaulators
- State of the art
- What to do: R&Q recommend next steps
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