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Evaluation ViewAttendees 1

Pre-Conference Workshop

Digital Health

Pre-Conference Workshop: Technical Documentation Assessment of MDSW-a Notified Body Perspective

Tuesday, May 5, 2026
08:30 - 16:00 WEST
Location: Pavilion 3 - Room 3B
Learning Level: Intermediate
Click here to download the agenda

Description: Medical device software (MDSW), in-vitro diagnostics medical device software (IVD MDSW), and devices incorporating artificial intelligence (AI) are playing an increasingly critical role in the medical device and diagnostics industry.
With the change of the EU regulatory framework, such devices place at the intersection of various sectorial requirements such as the ones from MDR/IVDR, AI act, and cybersecurity standards.

Answering requirements of the applicable regulations within the adequate timeline is critical for all manufacturers and notified bodies intending to place or continue to place MDSW, IVD MDSW and AI-enabled devices in the EU market. As with any medical device or IVD, the assessment of technical documentation (TD) is a critical part of the conformity assessment process to demonstrate compliance with current EU regulations.

However, preparation and evaluation of TDs for MDSW, IVD MDSW, and AI-enabled devices present unique challenges to all stakeholders. Additionally, many of these devices are undergoing assessment by a notified body for the first time. Consistent and higher-quality TD files will facilitate the assessment by notified bodies and positively impact the speed at which the conformity assessment can be completed. This will also allow for more predictable timelines for both manufacturers and notified bodies.

This workshop will offer essential insights into the expectations of notified bodies for MDSW, IVD MDSW, and AI-enabled devices. It will also feature an extensive session on common pitfalls and provide tips for manufacturers to prepare for a successful conformity assessment process.

Learning Objectives:

  • Upon completion, participants will acquire insights into the challenges in assessing of the technical documentation-specific MDSW and devices incorporating AI both from an MDR and IVDR perspective.
  • Upon completion, participants will be able to support the preparation of technical documentation files for IVDR/MDR conformity assessment for devices incorporating AI, MDSW and IVD MDSW.
  • Upon completion, participants will be able to take informed decisions on critical elements of the technical documentation for devices incorporating AI and MDSW/IVD MDSW to prepare for a successful conformity assessment process.