Key MDR compliance requirements and challenges

An effective roadmap to MDR compliance involves multiple components. MDR requirements, such as conformity assessments and sufficient clinical evidence, are more expansive and complex than those of the MDD, which means manufacturers must now address issues including:

  • Total product lifecycle approach to CE Marking certification
  • Learn how MDR affects human factors engineering and usability requirements via our this webinar
  • Enhanced post-market surveillance and post-market clinical follow-up (PMCF) requirements
  • Notified Body capacity: When does your NB plan to obtain MDR designation?
  • Changes to European Authorized Representative (AR) roles and agreements
  • Eudamed database submission requirements for manufacturers, devices and other economic operators

Download our MDR Readiness Checklist?to quickly assess your level of compliance with the new regulation and identify next steps.

How we help

Emergo by UL consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR.

Our MDR Team

Our EU consultants have decades of experience in medical device regulatory affairs, human factors, clinical research, and cybersecurity. Meet our MDR team

Alexandre-Pétiard
Alexandre Pétiard
Senior Consultant, Quality and Regulatory Affairs
Meet Alexandre
Daryl-Wisdahl
Daryl Wisdahl
Senior Consultant, Quality and Regulatory Affairs
Meet Daryl
Dietmar Falke
Dietmar Falke, PhD
Consultant, Clinical Research (Europe)
Meet Dietmar

Elizabeth Pugh
Elizabeth Pugh
Senior Consultant, Regulatory Affairs (North America)
Meet Elizabeth
Evangeline-Loh
Evangeline Loh, PhD, RAC
Global Manager, Regulatory Affairs (North America)
Meet Evangeline
Yvonne Limpens
Yvonne Limpens
Managing Human Factors Specialist (Europe)
Meet Yvonne
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