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Medical Devices

The Mystic Neighbour: Notified Body Oversight with a Watch on SOTA, Risk, PMS, and Claims

Wednesday, May 6, 2026
14:30 - 15:30 WEST
Location: Pavilion 3
Learning Level: Advanced
Description: In this interactive role play, the MaDeR family is joined by their watchful mystic neighbour, the Notified Body. Ever observant, the neighbour looks in through the window and occasionally steps inside to challenge the family with critical remarks.

The Notified Body does not just focus on what Auntie Claim communicates about the families’ medical devices or what data Son PMS collects; he also points repeatedly to Grandpa SOTA, the embodiment of state of the art. For the neighbour, Grandpa SOTA‘s wisdom defines the benchmarks, minimum standards and derived acceptance criteria that are fundamental input for medical device development, clinical evaluation, risk management and claims for marketing.

At the same time, the neighbour never forgets the current absent family members: Clinical and Risk. Their absence creates gaps and inconsistencies that the Notified Body immediately highlights — reminding everyone that PMS data, claims, risk management, and clinical evaluation are interdependent and must stay aligned under MDR.

Through humour, role play, and audience interaction, the session brings to life the constant tension between internal enthusiasm and external oversight, and shows how , while showing how the proactive, SOTA-guided integration of processes reduces findings and builds confidence.

Learning Objectives:

  • Upon completion, participants will be able to understand how notified bodies use state of the art as a benchmark when reviewing clinical, risk, PMS, and claims documentation.
  • Upon completion, participants will be able to recognize how gaps or inconsistencies arise when processes are not aligned, and how NB scrutiny exposes them.
  • Upon completion, participants will be able to apply strategies to integrate SOTA, PMS, claims, and risk considerations for greater consistency and smoother NB interactions.