Don't let the holidays delay your 2026 regulatory compliance.
Don't let the holidays delay your 2026 regulatory compliance.
For medical device manufacturers, Q4 isn't just about finishing the year; it's the final, critical window to align your 2026 Regulatory Blueprint with emerging global deadlines.
The next 12-18 months contain key shifts you must budget and plan for now:
EUDAMED & UDI Mandates: The mandatory use of the EUDAMED UDI/Device Registration modules is rolling out starting Q1 2026. Data quality and system integration must be Q1 projects, not Q3 emergencies.
The FDA's QMSR: The transition to the new Quality Management System Regulation (QMSR) is effective February 2, 2026. This requires a final gap assessment and QMS update before year-end to ensure your systems are ready for global harmonisation.
UK Regulatory Reform: New UK Post-Market Surveillance (PMS) rules came into effect in June 2025. Is your system updated to meet the stricter, UK-specific reporting and data requirements, or risk non-compliance in a core market?
The Strategic Imperative: Regulatory work is no longer just a cost centre—it's a competitive filter. Those who plan strategically now will achieve faster market access, reduce the risk of Notified Body findings, and turn compliance into a competitive advantage.
Ready to build a robust 2026 plan? Let's discuss your priorities, from ISO 13485 alignment to SaMD strategy. DM me to secure a strategic review session before the end of the year.
What’s the one regulatory project you are prioritizing for Q1 2026? 👇
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