Continuous MedTech Oversight Comes of Age

MedTech Leading Voice | Issue 173

📝 From the Editor

This week's posts circle one expectation: proof that holds up after clearance. Cybersecurity convergence, AI-device authorization, lifecycle-versus-lifetime distinctions, and zero-day readiness all point to the same place.

I also joined Etienne Nichols on the Greenlight Guru Global Medical Device Podcast this month to talk about the MLV 100 and what I've learned building this community. Have a listen here. — Sean Smith

🧠 Featured Post

EU and U.S. Cybersecurity Rules Converge

The convergence of EU and U.S. medical device cybersecurity requirements was examined by Emma Johnson.

With the EU Cyber Resilience Act obligations arriving on September 11, 2026, manufacturers face overlapping EU and U.S. cybersecurity expectations across a device's full lifecycle, not just at market entry.

Map both frameworks against your product portfolio now, so post-market monitoring, vulnerability handling, and evidence hold up on either side of the Atlantic. View the post >>

📌 This Week's Top Posts (In no special order)

• The evolving IEC 60601-1 4th Edition and its broader standards impact, explored by Leonard Eisner.
• EU MDR Compliance clarified the distinctions between lifecycle, shelf life, and lifetime for medical devices.
• The strategic implications of proposed MDUFA VI changes for medtech startups were outlined by Alex Kosik.
• Mario Gabrielli Cossellu announced the European Commission's updated list of Notified Body standard fees.
• The convergence of EU and U.S. medical device cybersecurity requirements was examined by Emma Johnson.
• Dr. Ebot Eyong detailed the top regulatory challenges facing AI-based medical devices seeking FDA authorization.
• New EU MDR amendments expanding regulatory flexibility were analyzed by MFA Legal & Tech.
• Jose Bohorquez discussed the importance of preparing for zero-day vulnerabilities in connected medical devices.
• A unified approach to managing safety and cybersecurity risks under ISO 14971 was recommended by Medical Device HQ.
• Georg Digel highlighted the importance of writing effective problem statements for successful CAPA investigations.
• The MDR implications for research-use-only products and health institutions were overviewed by Francesco Ambrosio.

🧠 Featured Article

The FDA Authorized 86 AI Medical Devices in 90 Days. That’s Not the Real Story.

Yujan Shrestha, MD, reported that AI/ML medical-device authorizations held steady in Q2 2026, with 86 devices reaching the market.

The more revealing story is what happened after initial clearance: companies changed algorithms, outputs, patient populations, deployment models, and clinical workflows, sometimes in as little as 29 days.

Innolitics’ new analysis shows why the winners in medical AI will be the companies that design for continuous regulatory change, not simply the first clearance. Read the full analysis.

🎯 Featured Event

MDUFA VI: What Every MedTech Company Needs to Know Now.

The next Medical Device User Fee Amendments (MDUFA VI) won't take effect until FY 2028, but the draft agreement offers an early look at where the FDA's medical device program is headed.

Join David Filmore (Market Pathways), Executive Editor, for a practical discussion of what the proposed agreement means for MedTech companies: proposed changes to the Pre-Submission program, FDA review capacity, FDA-CMS collaboration, and other provisions that could shape device development and regulatory strategy for years to come. Bring your questions for a live audience Q&A.

Fri, Jul 24, 2026 | 11:00 AM ET Register Now >>

🗓️ Upcoming Events & Webinars

• July 24, 2026 | 11:00 AM ET — MDUFA VI: What Every MedTech Company Needs to Know Now, featuring David Filmore (Market Pathways). Register Now >>
• July 31, 2026 | 11:00 AM ET — Designing Electronic Medical Devices That Actually Reach Production, featuring Andre DiMino (ADCO Manufacturing). Registration coming soon.
• August 19, 2026 | 11:00 AM ET — When Enrollment Stops: Diagnosing a Study That's Already Gone Wrong, featuring Daniela Karrer (Donawa Lifescience), moderated by Sean Smith. Register Now >>

🌍 Evento en español

• 24 de julio de 2026 | 12h30–14h (UTC+2) — EUDAMED y registro nacional RECOPS en España, evento virtual gratuito de RAPS Spain Local Networking Group, con Raquel Carnero (IQVIA), Claire Murphy y Xavier Canals-Riera (Tecno-med Ingenieros). Cualquier operador económico que comercialice productos sanitarios en España debe, además de estar registrado en EUDAMED, figurar en el registro RECOPS de la AEMPS. La sesión explica los pasos para cumplir estas obligaciones y mantener el cumplimiento regulatorio en toda la cadena de suministro. Abierto a no miembros de RAPS. Regístrate ahora >>

💥 Weekly 510(k) Roundup

July 13, 2026 | From Marcus Engineering, LLC

45 clearances this week, including 10 first-time clearances (🚀).

Featured first-time clearances:

• BlueDop Medical, Ltd. 🚀 — BlueDop Vascular Expert: a Doppler ultrasound system for assessing Peripheral Arterial Disease without the discomfort of cuff-based testing.
• Avara Software 🚀 — Avara Viewer: cleared in just 17 days.
• Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) 🚀 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA.

Explore the update >>

📋 Regulatory Roundup

July 13, 2026 | By Martin King

Regulators are moving from point-in-time approvals to continuous lifecycle oversight. FDA expanded the TAP programme, the MHRA invested in regulatory-grade health data and innovation pathways, and Team-NB proposed risk-adaptive MDR and IVDR surveillance. ANVISA advanced digital prescription and regulatory systems, while Malaysia's Medical Device Authority and China's NMPA expanded collaborative device reviews. Digital regulatory capability, real-world data, post-market surveillance, and lifecycle compliance are now the strategic differentiators for manufacturers.

Explore the update >>

🎤 In Case You Missed It

Pharma & MedTech Information: Why It Matters More Than Ever

July 17, 2026 — Sean Smith hosted Diana Gowe (Johnson & Johnson), Chair of the Pharma and MedTech Information group (PHMTI), and Samantha Intriligator (Regeneron) for a Friday In-Focus conversation on how information professionals find, judge, and use publicly available information across pharma and medtech.

The through-line: finding what matters, judging it, and using it well is the work, and the human stays in the loop. Panelists and audience members walked through a typical medtech research workflow, starting with the FDA product code database and 510(k) predicates, then clinical trials, PubMed, and patents. On AI, the room agreed it is a force multiplier for culling and summarizing, not a replacement for human experience and judgment, and that guardrails and vetted source data matter most in a regulated environment. PHMTI's fourth annual fall seminar, focused on AI's impact on information work, will be held at the Sofitel at Rittenhouse Square in Philadelphia.

Watch the replay >>

🔥 Postscript

Meet me in Prague for the TEAM-PRRC Annual Summit

October 29-30, 2026, at the Pague, Hilton Old Town, the key European event for PRRCs and regulatory affairs professionals. Register Now >>

Sean 🐝