On 18 May 2026, the European Medicines Agency (EMA) published the highlights from its third workshop bringing together expert panels and notified bodies, focusing on the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The workshop aimed to improve consistency in the assessment of medical devices and diagnostics, addressing ongoing challenges in the certification process.
The document, issued by EMA's Medical Devices sector, summarizes discussions held during the workshop, which included representatives from expert panels, notified bodies, and the European Commission. Key topics included the role of expert panels in providing scientific opinions, the interface between notified bodies and expert panels, and the use of clinical evaluation guidance. The workshop also covered the handling of significant changes in device design and the application of the new regulations to legacy devices.
No new regulatory measures were announced; instead, the document serves as a record of the workshop's outcomes and recommendations. It highlights areas where further harmonization is needed, such as the interpretation of clinical data requirements and the criteria for designating notified bodies. The workshop also discussed the need for clearer guidance on the scope of expert panel consultations.
Stakeholders impacted include medical device manufacturers, who face continued uncertainty in certification timelines and costs; notified bodies, which are under pressure to increase capacity and consistency; and healthcare providers and patients, who rely on timely access to safe and effective devices. The workshop's emphasis on harmonization may reduce variability in assessments, potentially streamlining the certification process over time, but the lack of concrete new measures means immediate relief for manufacturers is limited.
EMA is expected to continue facilitating dialogue between expert panels and notified bodies, with further workshops planned. The European Commission may use the workshop's findings to inform future guidance or legislative adjustments to the MDR and IVDR frameworks.
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