Is your medical device a high-risk AI system under the EU AI Act?
Find out in five questions.
Of 1,357 AI medical devices cleared by the FDA, only 3 were ever evaluated against patient outcomes. Regulators on both sides of the Atlantic are reacting, and in the EU the rules are already law. Check your device in two minutes, then get the free AI Act × MDR/IVDR Integration Checklist as a PDF.
The evidence gap is now public.
A peer-reviewed study published on August 19, 2026 examined every AI medical device authorized by the FDA. One day earlier, the FDA opened a discussion paper on generative AI devices. Buyers, payers and journalists now ask governance questions before clinical ones.
Source: Abulibdeh et al., PLOS Digital Health, August 19, 2026
The 2-minute high-risk check
Five questions, straight from Article 6(1) of the AI Act and the MDCG 2025-6 guidance. Enter your email once, it unlocks the check and the PDF checklist. At the end you see how your device is likely classified and what that means for your timeline.
One step before the questions
Enter your details once, and both the check and the PDF checklist unlock immediately.
What's inside the PDF
Eight pages, no fluff. The working document your Regulatory Affairs and Commercial teams can put on the table this quarter.
The 5-question scope check
The same check as on this page, as a printable worksheet for every product and pipeline candidate, with the notified-body classes spelled out.
The Article 8(2) integration map
All eleven AI Act duties mapped to where they land in your existing MDR/IVDR technical file, from ISO 14971 to PMS, with one integration tip per row. No parallel compliance universe.
The real-world evidence roadmap
Five steps from “cleared” to evidence-backed: audit your claims, pick outcome endpoints buyers pay for, and use the PMCF machinery you already own.
Your first 90 days
A week-by-week plan plus six board-ready questions, and the deadlines to put in your calendar, including the FDA comment window closing October 19, 2026.
Get the checklist
One email unlocks the check above and this download. Forward the PDF to your RA lead afterwards, that is exactly what it is made for.
The AI Act × MDR/IVDR Integration Checklist
8 pages · PDF · English · free
The download unlocks together with the 2-minute check above, one email, both doors open.
Unlock with your emailDone, the checklist is yours.
Download it right here. If you confirm the opt-in email, you will also get my occasional AI insights for Life Sciences.
Want this mapped to your own portfolio? In 30 minutes we can walk through your products and see where the real gaps are.
Book a free strategy callWhy me?
I am Selina Gaertner, AI strategy consultant with a TÜV-Rheinland-certified qualification and ten years of sales and marketing leadership in international MedTech companies. That is why I look at AI regulation the way your customers do: as a buying decision.
I help leadership teams turn exactly the topics in this checklist into an executable plan: scope assessment across the portfolio, one integrated AI Act plus MDR/IVDR workstream, and an evidence strategy your commercial team can sell with.
“AI is a business model question, not an IT ticket.”
Book a free 30-minute callThis page and the checklist are provided for general information based on Regulation (EU) 2024/1689 (AI Act), the MDR/IVDR and the joint AIB 2025-1 / MDCG 2025-6 guidance, as of August 2026. They are not legal or regulatory advice and do not replace consultation with your notified body or qualified counsel. The check gives an initial orientation, not a formal classification.