Regulatory Insights

EU MDR Audit Trends 2026: What Notified Bodies Are Focusing On

As the EU Medical Device Regulation matures into its full enforcement phase, the pattern of Notified Body audit findings is becoming clearer. Across 2025 and into 2026, three recurring themes have emerged in audit reports and industry feedback: clinical evidence traceability, Post-Market Surveillance system robustness, and the completeness of economic operator documentation chains.

For manufacturers who entered the MDR pathway under transition provisions, the expectation has now shifted significantly. Initial certification audits gave many companies a degree of latitude; renewal and surveillance audits are being conducted at a considerably higher standard. Notified Bodies are spending more time on PMS plans and their connection to the clinical evaluation update cycle — a gap that many manufacturers underestimated during initial submission.

The second major trend is technical documentation traceability. Auditors are specifically looking at whether risk management outputs are consistently reflected across the technical file — from the risk management report through to design verification, post-market data, and labelling decisions. Disconnected documentation structures that were accepted during early certification are now generating non-conformances.

Discuss your MDR readiness

Why eQMS Implementations Fail — And What to Do Before You Start

The decision to implement an electronic Quality Management System is often driven by the right instincts: reduce paper burden, improve traceability, make audit preparation faster. But a significant proportion of eQMS implementations either fail outright or deliver systems that are more burdensome than the paper processes they replaced.

The core problem is almost never the software. The problem is that organisations implement a digital system on top of processes that were already broken. An eQMS does not fix a poorly designed CAPA process — it amplifies its weaknesses and embeds them into software logic that is difficult to change later.

The organisations that achieve successful eQMS deployments almost always follow the same sequence: process simplification first, then system selection, then configuration. Jumping directly to vendor selection without first cleaning up the underlying quality system is where most projects run into difficulty.

Talk to us about eQMS strategy