-
MDR clinical evidence expectations remain challenging and variable
While EU MDR is harmonised in text, its interpretation and application across Notified Bodies is not yet consistent in practice. Differences in reviewer expertise, depth of scrutiny, backlog pressures, and authority preferences meaningfully impact timelines and budgets.
As a result, manufacturers must build flexibility into their global clinical strategy — including preparedness for NB selection and engagement from the earliest planning stages.
-
“Sufficient clinical evidence” still lacks a universal definition
There is no precise, common specification that defines what is “sufficient” — neither in the core MDR text nor in the latest MDR proposals. Even well-established guidance like MDCG templates and CORE-MD efforts are evolving.
Notified Bodies continually strive to harmonise expectations (e.g., through Team-NB exchanges and position papers), but manufacturers still face practical differences in interpretation day-to-day.
-
Clinical Evaluation (CER) vs Post-Market Clinical Follow-Up (PMCF) — two distinct, vital elements
A strong CER validates safety/performance at conformity assessment, whereas PMCF ensures ongoing evidence throughout the lifecycle.
A key success factor is linking the CER and PMCF rationally, especially where evidence gaps identified during evaluation are explicitly addressed by PMCF activities.
-
Craft realistic evidence plans — avoid over-commitment
Overly ambitious clinical strategies have real consequences. More data can mean more risk — the rrelevant data reduces it. The MDR places a heavy burden on post-market obligations — particularly PMCF — which, if not justified proportionately, can erode profit margins and strain resources.
Panel consensus: aim for clinical evidence strategies that are rigorous but pragmatic — optimised for MDR compliance and operational sustainability.
-
Real-World Evidence (RWE) and high-quality surveys
Leverage alternative data sources such as high-grade real-world evidence and surveys — in supporting ongoing market access and PMS/PMCF obligations, particularly when traditional trial data is expensive or impractical.
The quality of data collection (e.g., scientifically sound survey design) is essential for regulatory credibility.
Key takeaways
A clear and consistent message emerged: manufacturers must have a robust and forward-looking clinical development strategy. PMCF should not be a box ticking exercise or a repetition of what is already known. Instead, it needs to be PMCF with purpose—designed to address scientific questions about the unknowns identified in the Clinical Evaluation, such as:
- performance in specific subpopulations
- longer term safety and performance data
Without this strategic alignment, meeting expectations under the MDR becomes increasingly challenging.
Bottom line for medtech leaders:
- Plan early for NB variability and integrate clinical strategy with regulatory and quality functions
- Build evidence plans that are robust but realistic
- Link CER and PMCF with clear rationale and measurable objectives
- Leverage RWE thoughtfully to support long-term compliance
