Bioexcelife
Introduction
The European regulatory landscape is evolving once again. With the upcoming MDCG 2025 guidance, medical device manufacturers face a major shift in how post-market vigilance is managed. Trend reporting — once seen as optional or secondary — is now a mandatory requirement.
This change will fundamentally reshape how manufacturers track, analyse, and report device performance in the field. More importantly, it reinforces Europe’s commitment to proactive patient safety.
What’s Changing?
Under MDCG 2025, manufacturers must detect and report:
- Non-serious incidents
- Expected side effects
- Erroneous results
But here’s the new twist: reporting is required when these events show statistically significant increases compared to historical or expected performance.
In other words, regulators now expect companies to:
✔ Establish clear statistical thresholds
✔ Track device performance globally in near real time
✔ Demonstrate integration of PMS (Post-Market Surveillance) with QMS (Quality Management System)
✔ Maintain ready-to-submit reports aligned with EUDAMED vigilance requirements
Why It Matters
This isn’t just another paperwork exercise. Trend reporting acts as an early-warning system:
- It highlights subtle but important shifts in safety profiles.
- It empowers manufacturers to detect issues before they escalate into recalls or FSCA actions.
- It reassures regulators that the manufacturer has tight control over post-market risk management.
Failing to comply won’t just slow down your audits—it could put your CE marking and market access at risk.
How to Stay Ahead: Technology + Expertise
Manual vigilance tracking simply won’t cut it under MDCG 2025. At Bioexcel, we’ve combined regulatory expertise with VigiX — our AI-powered materiovigilance platform — to help manufacturers meet these new demands with ease.
Here’s how VigiX supports you:
👉 Automated Trend Detection – real-time algorithms to spot statistically significant shifts
👉 Global Data Integration – combines complaints, literature, registries, and feedback into a unified dashboard
👉 MTR-Ready Reports for EUDAMED – structured outputs aligned with EU vigilance formats
👉 Regulator-Ready Documentation – seamless integration with PMS + QMS records
The result: faster reporting, reduced compliance burden, and stronger regulator confidence.
What It Means for Manufacturers
- Proactive Compliance: You don’t wait for issues to pile up; you detect and address them early.
- Operational Efficiency: Automated systems replace manual spreadsheets and fragmented tracking.
- Regulatory Confidence: Demonstrating trend reporting competence strengthens your CE submissions and audits.
- Patient Safety: Ultimately, this shift prioritises patients — and companies that adapt quickly will earn trust and reputation benefits.
The Bottom Line
MDCG 2025 is not just a regulatory update — it’s a paradigm shift in vigilance. Manufacturers must embrace trend reporting as a core part of their post-market strategy, not a box-ticking exercise.
With the right tools and processes in place, this doesn’t have to be a burden. Instead, it can become a competitive advantage — proving to regulators, partners, and patients that your organisation prioritises safety, compliance, and innovation.
At Bioexcel, we’re ready to guide you through this transition with VigiX materiovigilance automation.
💡Want to see how VigiX can simplify your MDCG 2025 compliance?
