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Medical Devices

Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead

Wednesday, May 6, 2026
14:30 - 15:30 WEST
Location: Auditorium 2
Learning Level: Advanced
Description: Clinical evidence is the cornerstone of compliance under Regulation (EU) 2017/745. The transition from the pre-MDR framework in Directive 93/42/EEC (Annex X) to the reinforced requirements of MDR Annex XIV has significantly raised expectations on the sufficiency and robustness of data, requiring both manufacturers and notified bodies to adopt more rigorous and continuously updated approaches.

This session will share lessons from notified body assessments, highlighting recurrent pitfalls in clinical evaluation reports. Guidance documents and regulatory practice are shaping these evaluations, yet challenges remain—not only for legacy devices transitioning to MDR, but also for innovative technologies.

The discussion will emphasize how integrating clinical evaluation, risk management, and post-market surveillance into a coherent lifecycle strategy strengthens both compliance and patient safety. Special attention will be given to the increasing importance of the link between risk assessment and clinical data, illustrated through a case study of expert panel consultation on an innovative high-risk implantable device.

By combining regulatory insights with practical experience, the session will demonstrate how robust clinical strategies can not only meet compliance requirements but also build transparency, trust, and confidence in the European regulatory system.

Learning Objectives:

  • Upon completion, participants will be able to identify common pitfalls in clinical evaluation reports under MDR and explain how to avoid them in practice.
  • Upon completion, participants will be able to integrate clinical evaluation, risk management, and post-market surveillance into a coherent lifecycle strategy that meets MDR requirements.
  • Upon completion, participants will be able to apply insights from notified body experience and expert panel consultations to strengthen clinical strategies for both legacy and innovative high-risk devices.