Key IVDR compliance requirements and challenges

Creating an actionable roadmap to IVDR compliance is a complex process. The IVDR introduces new concepts and stricter requirements, including new activities such as clinical data gathering and usability engineering (UE) standards compared to the previous European In Vitro Diagnostic Medical Devices Directive (IVDD), which means manufacturers must now address issues including:

  • Risk-based classification that will newly require Notified Body intervention for many IVD types
  • Total product lifecycle approach to CE Marking certification
  • Enhanced post-market surveillance (PMS) and post-market performance follow-up (PMPF) requirements
  • Notified Body capacity: Does your NB plan to obtain IVDR designation, and if so, when?
  • Changes to European Authorized Representative (AR) roles and agreements
  • Eudamed database submission requirements for manufacturers, devices and other economic operators

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

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How We Help

Emergo by UL consultants are ready to fully support your CE Marking transition from the In Vitro Diagnostic Medical Devices Directive (IVDD) to the IVDR.

Our IVDR Team

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

Alexandre Pétiard
Senior Consultant, Quality and Regulatory Affairs
Meet Alexandre
Evangeline Loh, PhD, RAC
Global Manager, Regulatory Affairs (North America)
Ken Pilgrim
Ken Pilgrim
Manager, Regulatory Affairs

Lilian Pinheiro
Lilian Pinheiro
Consultant, Regulatory Affairs (Latin America)
Oliver Eikenberg
Oliver Eikenberg, PhD
Senior Consultant, Quality and Regulatory Affairs
Dietmar Falke
Dietmar Falke
Senior Consultant, Clinical Research (Europe)