Clinical Evaluation Updates: When Are They Really Required?
Many medical device manufacturers are familiar with the situation: the clinical evaluation is complete, the PMS process is running, the next submission or notified body surveillance is approaching, and suddenly the question arises: does the Clinical Evaluation Report (CER) really need to be updated now? In practice, this question is often answered using fixed intervals: […]
WET List, Delegated Act and MDR 2.0: Why Manufacturers Now Need a Robust Strategy
On May 27, 2026, the PRO-LIANCE Learning Update Factory took place, focusing on the WET List and the Delegated Act of March 2026. The central question addressed, one that currently concerns many manufacturers of implantable and Class III medical devices, was: What does the planned expansion of the so-called Well-Established Technologies list mean in practice for […]