MDCG 2025-X Trend Reporting Q&A: Trend Reporting Gets Concrete

September 28, 2025 | Issue 131 — Trend Reporting Gets Concrete

From the Editor ✍🏽

Issue 131 zeroes in on EU MDR/IVDR trend reporting with a clean explainer you can act on now—plus vigilance essentials, clinical-evidence upgrades, AI compliance guidance, prototype-phase biocomp, explainable cardiovascular AI, equity checklists for digital health, FDA submission tips, and smarter compliance workflows.

Featured Webinar - EU AI Act Countdown: Critical Actions Medical Device Companies Must Take Before 202

💥 This Week’s Top Posts – In Brief

(In no special order)

• Biocompatibility at prototype phase: An infographic on ways to integrate biocompatibility at the prototype phase to prevent risks was shared by Marina Daineko.
• MDR/IVDR trend reporting: Stefano Bolletta highlighted the MDCG 2025-X draft guideline, discussing Q&A on trend reporting requirements under the EU MDR and IVDR.
• Explainable AI in cardiovascular health: Danny Van Roijen detailed a JRC report on explainable AI in cardiovascular health, stressing transparency, multimodality, and clinician context.
• Digital health equity: 20 ways to ensure digital health technologies reduce health disparities, outlined in a helpful infographic by Sigrid Berge van Rooijen
• Clinical evaluation evidence: EU MDR Compliance underscored a step-by-step guide on turning clinical data into meaningful insight for evaluations.
• Responsible AI innovation: A useful playbook, “Advancing Responsible AI Innovation”, was summarized in 9 key points by Simon Philip Rost.
• Vigilance reporting: Tibor Zechmeister presented a vigilance reporting cheat sheet covering triggers, timelines, and best practices for MedTech teams.
• Dual compliance (MDR/IVDR + EU AI Act): Dr. Pallavi Dasgupta explained the dual compliance challenge of complying with both MDR/IVDR and the EU AI Act for AI-enabled devices.
• AI/ML SaMD adjudication: A definitive guide to AI/ML SaMD adjudication with protocols and decision trees was written by Yujan Shrestha.
• FDA submission best practices: Michelle Lott overviewed ten tips for a bulletproof FDA submission in her recent blog post.
• Compliance process optimization: 5 strategies to streamline compliance processes, broken down by Bastian Krapinger-Ruether

📊 Featured Post — MDCG 2025-X Trend Reporting Q&A

Trend reporting gets concrete—this Q&A pins down thresholds, data sources, and roles so PMS stops guessing.

Stefano Bolletta shared the new draft guideline, which lays out how manufacturers should detect and report statistically significant increases in incident rates under EU MDR/IVDR, clarifies who owns what inside PMS, and shows how to justify methods in your tech docs.

In short

• Sets clear expectations for thresholds, methods, and data windows used in trend detection.
• Aligns PMS, vigilance, and CER/PMCF so evidence flows in one direction.
• Reduces NB back-and-forth with documented rationales and repeatable calculations.
• Helps teams avoid under-reporting risk while controlling false alarms.

How to comply

1. Add a trend-reporting section to your PMS plan with formulas, data sources, and review cadence.
2. Build a small R script or spreadsheet to run control charts and auto-flag rates above thresholds.
3. Pre-write a Trend Assessment Note template: signal description, method, result, action.
4. Train RA/QA and clinical teams on hand-offs and escalation criteria; schedule a quarterly mock run.
5. Brief your notified body with a one-pager showing method, thresholds, and example outputs.

Sections ✅

🛡️ Regulatory Roundup by Martin King | September 22, 2025

New updates from:🔹 𝗜𝗻𝗱𝗶𝗮 - Indian Council of Medical Research (ICMR)– Central Drugs Standard Control OrganizationCDSCO issues standard protocols for IVD performance evaluation.🔹 𝗘𝗨- New Draft MDCG Q&A on trend reporting; European Medicines Agency EMA mandates MAHs to monitor EudraVigilance; CHMP recommends 14 new medicines.🔹 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 - European Union Agency for Cybersecurity (ENISA) on health sector cyber hygiene; 𝗡𝗜𝗦𝗧 launches lightweight cryptography standard for small/connected devices.🔹 𝗜𝗖𝗛 - E11A paediatric extrapolation case study; Q3E draft on extractables & leachables.🔹 𝗖𝗵𝗶𝗻𝗮 & 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 — NMPA-National Medical Products Administration self-inspection/verification; MDA CAB verification pathways.🔹 Swissmedic — new eDok submission guidance and forms.🔹 Therapeutic Goods Administration 𝗧𝗚𝗔 (𝗔𝘂𝘀𝘁𝗿𝗮𝗹𝗶𝗮) — revised Essential Principles checklist.🔹 FDA (𝗨𝗦) — Guidance on GERD (NERD & erosive esophagitis), coccidioidomycosis, safety labelling changes, and clinical lactation studies.🔹 Health Products Regulatory Authority (HPRA) (𝗜𝗿𝗲𝗹𝗮𝗻𝗱) — 2024 report: 462 authorisations, 7,885 ADRs, 3,672 device vigilance cases.🔸 Plus: European Medicines AgencyE MA veterinary medicines data guide & worksharing template; Medicines and Healthcare products Regulatory Agency MHRA International Recognition Procedure update.

👉 Powered by Hoodin.

📈 510(k)s at a Glance for the week of September 22, 2025

Marcus Engineering, LLC highlighted 52 new FDA 510(k) cleared devices last week, including 12 first-time 🚀 clearances.

👉 For full details, visit Marcus Engineering’s report.

📅 Upcoming Events

• 9/30 — "EU AI Act Countdown: Critical Actions Medical Device Companies Must Take Before 2027," MLV Webinar with AKRA TEAM (panel). Register
• 10/3 — "State of the Art and Startegy," MLVx In-Focus with Robert van Boxteland Jelle Schrauwen. Register
• 10/3 — "FDA Strategy 2025 Policy Pressures and the Path to MedTech Clearance," MLV Webinar with Michelle Lott. Register
• 10/7 - 10/9 — "RAPS Convergence 2025,"See you there!
• 11/05 — "2025 | Startup Symposium," by Project MedTech, Philadelphia, PA

🐝 PS — Check the new 1-Minute Webinar Recap of "Closing the Blind Spots: Designing Devices for the Real World"