Why clinical evaluation keeps MDR compliance alive after CE marking
Clinical evaluation and post-market planning in MDR, Episode 3 of MDR Made Simple webinar series
How clinical evidence and post-market data work together to demonstrate safety and performance throughout the device lifecycle.
If classification sets the direction and technical documentation provides the structure, then clinical evaluation is the ongoing health check that keeps an MDR-compliant device fit for market. In Episode 3 of our MDR Made Simple webinar series, we explored how clinical evaluation and post-market planning are central to demonstrating safety and performance, not just at CE marking, but continuously over time.
Under MDR, clinical evaluation is a systematic, evidence-based process defined in Annex XIV. It relies on clinical data sourced from clinical investigations, scientific literature, and post-market surveillance. This data is assessed, analysed, and documented through a structured process that includes planning, appraisal, analysis, and reporting. Each stage must be traceable, scientifically justified, and performed by qualified evaluators.
A key focus of the session was equivalence. MDR raises the bar significantly. Using data from another device is only acceptable when technical, biological, and clinical characteristics are truly comparable. Similarity is not enough. Without clear scientific justification, equivalence claims can quickly unravel during assessment.
Post-market surveillance closes the loop. Real-world data from post-market clinical follow-up, incident reports, and vigilance activities feeds back into the clinical evaluation, ensuring that safety and performance claims remain valid as the device is used in practice.
The key insight: clinical evaluation under MDR is not a one-time exercise. It is a continuous process that applies to all devices and evolves throughout their lifecycle.
As an MDR-designated Notified Body, DNV supports manufacturers in building robust clinical evaluation strategies that integrate pre-market evidence with post-market data, helping ensure compliance, continuity, and confidence in the EU market.
1/14/2026 2:27:00 AM
