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
Richard Featherstone
Richard Featherstone
Research Director, HFR&D
Meet Richard

Evangeline-Loh
Evangeline Loh, PhD, RAC
Global Manager, Regulatory Affairs
Meet Evangeline
Heather-Crawford
Heather Crawford
Senior Consultant, Quality and Regulatory Affairs
Meet Heather
Jaap-Laufer
Jaap Laufer
Medical Director and Senior Consultant
Meet Jaap

Blog

Get the latest industry insights from our MDR experts.  View All


Events

Learn from our experts through live webinars, workshops, and tradeshows. View All