What a Notified Body really looks for under IVDR and MDR

A practical lunch-time seminar with DNV

EU MDR and IVDR compliance is no longer only about meeting written requirements, it is about meeting Notified Body expectations in practice. Many Indian medical device and IVD manufacturers experience unexpected delays, repeated questions, or extended review cycles, often due to gaps in interpretation rather than intent.

This exclusive lunch-time seminar offers direct access to DNV as a Notified Body, providing clarity on how MDR and IVDR are applied during conformity assessment, what reviewers focus on, and how manufacturers can improve submission quality and predictability.

Rather than theoretical regulation walkthroughs, this session focuses on real-world assessment experience, common problem areas seen in submissions from India, and practical actions that manufacturers can take to reduce risk, rework, and timelines.

What you will gain
Participants will:

  • Gain practical insight into how Notified Bodies assess MDR and IVDR submissions in practice
  • Understand how to reduce delays and rework during conformity assessment and recertification
  • Learn what is expected across different technologies, including complex, software-driven, and AI-enabled products
  • Have the opportunity for direct interaction with DNV experts on submission-related questions

Who should participate
This session is particularly relevant for organisations involved in EU MDR and IVDR compliance, including those transitioning products, preparing submissions, or developing advanced technologies.

Exclusive leadership presence & one-to-one meetings
Senior DNV Life Sciences leadership will be present, including:

  • Geir Fuglerud, CEO, Life Sciences
  • Cecilie Torp Gudesen, Global Director of Medical services

Manufacturers may request one-to-one discussions on specific MDR or IVDR challenges after the session. Please contact Sathesh (Sathesh.Kumar.Annamalai@dnv.com) in advance to arrange a meeting slot.

Register now
Places are limited to maintain an interactive format.

Register here