Whitepaper: The MDR Transition Countdown | What medical device manufacturers need to know

Is your MDR transition on track? Learn what medical device manufacturers need to know about the final MDD deadlines, certification capacity and the proposed MDR 2.0 reforms

The extended MDR transition periods have given medical device manufacturers additional time, but they have not removed the work required to achieve MDR certification. For manufacturers with legacy devices still transitioning from MDD or AIMDD, the remaining window needs to accommodate technical documentation, Quality Management System readiness, conformity assessment activities, resolution of findings and the certification decision. 
 
At the same time, discussions around potential changes to the European medical device framework, often referred to as “MDR 2.0,” are creating new questions for manufacturers: Should you adjust your transition strategy, or continue working towards the requirements and deadlines already in place?

Intertek’s new whitepaper, The MDR Transition Countdown, explores:
  • The approaching 2027 and 2028 transition milestones
  • Why the extended transition periods remain conditional
  • Factors that can delay MDR conformity assessment
  • Practical actions manufacturers can take now
  • What the proposed MDR 2.0 reforms could mean
  • How manufacturers can reduce the risk of disruption to EU market access
Download The MDR Transition Countdown to understand the key transition milestones, potential certification challenges and what evolving MDR reforms could mean for your strategy.