MDR Transition Support
Bridge the gap from MDD to MDR
The shift from the MDD to the MDR is one of the most significant regulatory changes the medical device industry has faced in decades. QbD Group helps you navigate this transition.
Why early action is key
The shift from the MDD to the MDR is one of the most significant regulatory changes the medical device industry has faced in decades. While the MDD allowed for more flexibility, the MDR imposes more rigorous standards for safety, clinical evidence, and traceability.
The Medical Device Regulation (MDR) isn't just a new set of rules — it's a new playing field. Stricter scrutiny, increased documentation, and higher expectations for clinical evidence have changed the way medical devices are brought to market in the EU.
How we support you
At QbD Group, we help medical device companies bridge the gap from MDD to MDR with expert guidance, hands-on support, and a pragmatic strategy.
Gap assessment
Comprehensive assessment of your current MDD documentation against MDR requirements.
Transition strategy
Clear, actionable roadmap for your MDR transition journey.
Documentation upgrade
Upgrading your technical documentation to meet MDR standards.
NB coordination
Managing Notified Body interactions and submission planning.
Why QbD Group
Your trusted partner
Whether you're navigating legacy product rules or preparing your first MDR submission, we're here to make the transition as smooth — and successful — as possible.
Proven track record in successful MDD to MDR transitions.
Cross-functional expertise spanning QA, RA, and Technical Documentation.
Pragmatic approach aligned with your product portfolio and business goals.
Direct experience with Notified Body expectations and requirements.
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From regulatory strategy to product approval, our experts are ready to guide you through every step.