THREE OVERLOOKED MEDTECH EVIDENCE ENGINES

 MedTech Leading Voice | Weekly Rundown

September 14, 2025 | Issue 129 — Three Overlooked MedTech Evidence Engines

From the Editor ✍🏽

Your Issue 129 briefing: three overlooked MedTech evidence engines (human factors, real-world evidence, in-silico), the EU’s Call for Evidence on MDR/IVDR, a device-focused eIFU FAQ from last Friday’s MLVx session, ten featured posts, and the week’s regulatory and 510(k) roundups.

Featured Webinar - Three Overlooked MedTech Evidence Machines

New webinar Explores How Human Factors, Real-World Evidence, and In-Silico Testing Create Unbeatable Competitive Moats

While most MedTech companies burn through capital on traditional development pathways, industry leaders are quietly leveraging three evidence engines that slash time-to-market by years and create sustainable competitive advantages. Human factors testing, real-world evidence collection, and in-silico modeling represent strategic weapons that separate market winners from also-rans. Companies using these methods are reaching market two years earlier, saving millions in clinical trial costs, and building regulatory submissions that sail through approval processes.

The breakthrough lies in their integration.

When human factors informs real-world data collection, which then validates in-silico models, the result is an evidence package that regulators trust and a development process that eliminates expensive surprises that kill startups.

This Thursday, MLV is proud to partner with Project Medtech, presenting one of our most ambitious webinars to date—industry leaders from ClariMed, Inc., 3Aware, Dassault Systèmes, and Canon Medical sharing exactly how this integration creates genuine competitive moats.

Register now: https://www.linkedin.com/events/closingtheblindspots-designingd7371514432998363136/

💥 This Week’s Top Posts – In Brief

(In no special order)

• Merlin Rietschel flagged the European Commission’s Call for Evidence to revise MDR and IVDR. Policy window with potential changes to conformity, post-market requirements, and oversight; regulatory and exec teams should review and prepare input.
• Arne Jaksch outlined the implications of ECHA’s updated PFAS restriction proposal for analytical standards and the medical device sector. Material selection, testing, and supplier disclosures move up the agenda; assess bill of materials and lab methods now.
• Tibor Zechmeister shared an MDR Audit Readiness cheat sheet for MedTech leaders, covering pitfalls, documentation must-haves, training, and follow-up strategies. Use as a prep checklist ahead of surveillance and recert audits.
• Dr. Pallavi Dasgupta posted an infographic breaking down FDA biocompatibility expectations, workflows, and risk management integration. Clear map for study design, justification, and alignment with risk files to reduce rework.
• Jose Bohorquez highlighted a chapter from his medical device cybersecurity book on secure development. Threat modeling and secure SDLC from the start to reduce field risk and audit findings.
• Lisa Donlon detailed the third installment of the Annex XVI article series, focused on QMS adaptations and its emphasis on safety and performance. Practical guidance for teams working on borderline products and procedure updates.
• Intrinsic Medical Group published a helpful infographic on building a strong biological evaluation process. Tightens ISO 10993 strategy, documentation flow, and traceability across design, verification, and PMS.
• Georg Digel emphasized setting clear criteria when combining NC and CAPA processes in eQMS. Defines thresholds, ownership, and metrics to keep actions auditable and prevent repeats.
• Stefano Bolletta summarized the latest AI-enabled medical devices added to Australia’s ARTG. Useful market scan for competitor tracking, regulatory intelligence, and claims mapping in the AU market.
• Sigrid Berge van Rooijen broke down why healthcare is struggling to unlock AI’s potential across ethical, technological, medical, regulatory, trust, and data barriers. A compact framework to pressure-test AI roadmaps and messaging.

📊 Featured Post — EU Call for Evidence on a targeted MDR/IVDR revision

Last week, Merlin Rietchel shared that the European Commission opened a Call for Evidence to gather input for a proposal aimed at simplifying and streamlining MDR/IVDR. Indicative timing for the proposal: Q4 2025. Targeted consultations are planned, with a particular focus on SMEs. There will be no broad public consultation or impact assessment; instead, the proposal will be accompanied by an analytical staff working document. 

Key points at a glance

• Streamlined, proportionate conformity-assessment requirements, especially for low- and medium-risk devices. 
• Greater predictability and cost-efficiency in notified-body certification processes. 
• Further digitalisation, governance streamlining, and international cooperation. 
• Consultation via the Call for Evidence and targeted activities; emphasis on SME involvement. 
• Proposal preparation without an impact assessment; analytical staff document to present measures and evidence. 

👉 Share input on the Commission’s “Have Your Say” page

⚡ Featured Friday In-Focus Speaker — Michael Kania

Electronic IFU in Europe: a validated, content-based system for device labeling

In last week's MLVx Friday In-Focus webinar, Michael Kania, CEO of Meddevo, discussed how medical device teams structure eIFU (Electronic Instructions for Use) with a single source of truth, responsive content, clean version control, and audit-ready governance.

Here are seven FAQs Michael answers about eIFUs:

1. Which device categories qualify for eIFU under EU rules, and what justification must a MedTech manufacturer provide?
2. Can a home-use device or an implantable device use eIFU in the EU, and what extra controls do notified bodies expect?
3. What risk assessment must a device company complete before switching from paper IFU to eIFU?
4. What validation is required to qualify an eIFU platform as part of device labeling and the QMS?
5. What does a scalable, validated eIFU architecture look like for a MedTech device portfolio?
6. How should a device maker link UDI/UDI-PI to the correct eIFU version and maintain an accessible archive of prior device IFUs?
7. What “paper on request,” uptime, and access labeling must an EU device eIFU meet to satisfy 24/7 availability expectations?

▶️ Watch the replay on YouTube:https://youtu.be/afWLcvpUBdw?si=haRoZ77XJ9G1_k6X

Sections ✅

🛡️ Regulatory Roundup by Martin King | September 8, 2025

New updates from:🔹 𝗙𝗗𝗔 𝗥𝗮𝗿𝗲 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗘𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 (𝗥𝗗𝗘𝗣): a new pathway allowing approvals based on a single pivotal study plus supporting evidence. A game-changer for ultra-rare, genetically defined conditions.🔹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗖𝗮𝗻𝗮𝗱𝗮’𝘀 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝗚𝗠𝗣 𝗚𝘂𝗶𝗱𝗲 𝗳𝗼𝗿 𝗡𝗮𝘁𝘂𝗿𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀: expanded QMS, stability, and recall requirements, with compliance mandatory by 𝗠𝗮𝗿𝗰𝗵 𝟮𝟬𝟮𝟲.🔹 𝗜𝗠𝗗𝗥𝗙 & 𝗜𝗦𝗢 𝗵𝗮𝗿𝗺𝗼𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻: broad adoption of SaMD, UDI, cybersecurity, and AI/ML frameworks, though gaps remain in several regions.🔹 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗘𝘂𝗿𝗼𝗽𝗲 𝟮𝟬𝟮𝟱 𝗙𝗮𝗰𝘁𝘀 & 𝗙𝗶𝗴𝘂𝗿𝗲𝘀: €170B market, 38,000+ companies (90% SMEs), >930,000 employees; strong momentum in digital health reimbursement across Germany, France, and Belgium.

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📈 510(k)s at a Glance for the week of September 8, 2025

Marcus Engineering, LLC highlighted 49 new FDA 510(k) cleared devices last week, including 11 first-time 🚀 clearances.

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

📅 Upcoming MLV Events

• 9/18 — MLV Webinar — Closing the Blind Spots: Designing Devices for the Real World
• 9/19 — Smart RAQA Compliance for a Shifting Future | MLVx Friday In-Focus with Marcus Emne , Hoodin
• 9/26 — MLVx In-Focus with Kay Sim , ClariMed
• 9/30 — MLV Webinar — EU AI Act, with AKRA TEAM (panel)

🐝 PS — Please take our 3-Minute MedTech AI Survey → http://tiny.cc/MLVsurvey

Help shape future AI training and resources for RAQA professionals.