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 […]
From Silos to Synergy: Connecting Clinical Evaluation, Risk Management, and PMS/PMCF Under the MDR
Under Regulation (EU) 2017/745, aka MDR, medical device manufacturers face stricter requirements for demonstrating safety, performance, and clinical benefit throughout a product’s lifecycle. While many organizations treat Clinical Evaluation, Risk Management, and Post-Market Surveillance/Post-Market Clinical Follow-up (PMS/PMCF) as separate regulatory obligations, the MDR clearly expects these processes to be interconnected, forming a continuous feedback loop. […]
ISO/DIS 18969: Establishing a Global, Methodological Reference for Clinical Evaluation
The clinical evaluation of medical devices constitutes a fundamental element of regulatory conformity assessment across global markets. Regulatory frameworks such as Regulation (EU) 2017/745 for Medical Devices (MDR) establish legally binding requirements for clinical evaluation; however, they do not prescribe a fully harmonized and reproducible methodology for conducting, documenting, and maintaining clinical evaluations throughout the […]