The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.

In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.

The discussion covers:

Key shortcomings of the current MDR/IVDR framework

The impact on innovation, availability of devices, and SMEs

The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies

How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations

This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.

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.

Links 

 Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/

Social Media to follow

 Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

 Twitter:

 Pinterest: https://www.pinterest.com/easymedicaldevice

 Instagram: https://www.instagram.com/easymedicaldevice