A practical guide for manufacturers navigating EU MDR certification for substance-based medical devices.

Transitioning from MDD to MDR is one of the most complex regulatory challenges for SBMD manufacturers, especially with Notified Bodies raising the bar on technical documentation.

What you'll learn:

• Why SBMDs are among the most scrutinized device categories under EU MDR
• The most frequent non-conformities identified in technical files, and how to fix them
• What Notified Bodies actually expect in terms of scientific rationale and clinical evidence
• How legacy devices face unique reclassification and transition deadline risks
• How AzurBio's end-to-end approach reduces compliance risk and optimizes timelines

Each section reflects real regulatory findings, MDCG guidance alignment, and proven strategies that led to successful MDR certification.