Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities.
This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them:
- Understanding the shift from MDD to MDR (Article 61 & Annex XIV)
- Why weak Clinical Evaluation Plans (CEPs) lead to rejection
- How to generate and analyze real, device-specific clinical data
- Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system
- Maintaining a “living” Clinical Evaluation Report across the device lifecycle
👉 By following this checklist, you’ll not only pass your next review but also strengthen your evidence strategy for long-term compliance.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
