ENISA 2026: Cybersecurity priorities, clarified—Stakeholder roles, defined

MedTech Leading Voice | Issue 149

This week’s update focuses on Europe’s forward-looking cybersecurity agenda, implementation signals for MedTech manufacturers, audit and CAPA readiness, AI system safety expectations, evolving standards, and practical compliance tools to support 2026 planning.

📝 From the Editor

Danny Van Roijen shared a concise breakdown of ENISA’s 2026 Work Programme, outlining how cybersecurity priorities are being translated into coordinated action across regulators, industry, and supporting institutions.

ENISA’s planning documents often read abstractly. This one is different. The structure, sequencing, and stakeholder mapping point to where operational expectations are solidifying—particularly for regulated industries managing software, connected devices, and AI-enabled systems.

This week’s featured post looks at what the 2026 programme signals for MedTech teams building cybersecurity into quality systems, product design, and lifecycle oversight.

— Sean Smith, Publisher

🎯 Featured Post

EU CYBERSECURITY — ENISA’s 2026 Work Programme

Danny Van Roijen highlighted ENISA’s 2026 Work Programme priorities, focusing on how the agency is aligning threat intelligence, regulatory coordination, and operational guidance across the EU cybersecurity ecosystem.

The programme emphasizes:

• Clear role definition across manufacturers, notified bodies, national authorities, and supporting organizations
• Stronger integration between cybersecurity risk management, regulatory compliance, and operational resilience
• Continued development of shared tools, guidance, and coordination mechanisms supporting regulated sectors
• Forward-looking preparation for software-intensive and AI-enabled systems entering the market

For MedTech organizations, the programme offers useful context on how cybersecurity expectations are being shaped ahead of upcoming MDR, FDA, and horizontal EU cyber requirements. It provides a practical reference point for teams planning investments, governance structures, and cross-functional alignment in 2026 and beyond.

View the post >>

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

• Danny Van Roijen highlighted ENISA’s 2026 Work Programme priorities, along with its key stakeholder strategy.
• A practical CAPA audit question guide was detailed by Georg Digel ahead of FDA QMSR enforcement.
• Manfred Maiers walked through his recent article on designing an AI-ready FMEA database schema.
• A structured SALIENT framework for implementing clinical AI safely across workflow stages was shared by Sigrid Berge van Rooijen.
• Stefano Bolletta underscored the importance of robust cybersecurity and comprehensive pentesting for meeting MDR and FDA certification requirements.
• The new revision of ISO 10993-1 emphasizing extractables and extraction approaches was revealed by MedCore by Marina Daineko.
• In her recent Monday news, Marina Daineko summarized FDA priorities on Real-World Evidence, a packaging-related Early Alert, and upcoming career ecosystem events.
• Lucas R. Pianegonda underlined the four forces accelerating sustainable medical device development, from SBTi commitments to regulation.
• EU MDR Compliance overviewed eight foundational concepts for getting started with ISO 14971 risk management across the device lifecycle.
• Global UDI compliance requirements across the EU, US, and UK were overviewed in a cheat sheet by Tibor Zechmeister.
• Bastian Krapinger-Ruether mapped out a useful EU compliance cheat sheet for monitoring regulatory and standards changes.
• The importance of AI safety guardrails for patient-facing systems was emphasized by Robert Rogowski.
• John Nachtrieb discussed the critical role of packaging as an integral part of medical device design controls, in his recent article.

🗓️ Upcoming Events & Webinars

Friday, February 6, 2026 | 11:00 AM ET — The Anatomy of a Connected Medical Device, an interactive Friday In-Focus session featuring Mark Omo (Engineering Director & General Manager, Marcus Engineering, LLC), focused on demystifying the ecosystem behind modern connected medical devices. Register with one click >>

Tuesday, February 17, 2026 | 10:00 AM ET / 4:00 PM CET — ISO/DIS 18969: Introducing a Process-Based Approach to Clinical Evaluation, featuring subject matter experts Danielle Giroud (CEO, MD-CLINICALS SA, Chair of the ISO 18969 Working Group) and Maria E. Donawa, MD (Founder & President, Donawa Lifescience, Member of the ISO 18969 Working Group). This session will explain the background, intent, and structure of ISO/DIS 18969, a draft international standard introducing a lifecycle-integrated, process-based approach to clinical evaluation. Register Now >>

🔥 NOW with virtual attendance options: February 2–4, 2026 | Carlsbad, CA — Navigating Compliance for Medical Devices — Nemko & Eisner Safety Consultants - Three days of practical training on IEC 60601, EMC/RF, usability, software lifecycle, FDA/MDR expectations, and hands-on compliance. Discount code MLV10 for 10% off. Learn more >>

💥 Weekly 510(k) Roundup

January 26, 2026 | From Marcus Engineering, LLC

44 total clearances across multiple categories, including 6 first-time clearances (🚀)

• Cultiv8 1, LLC — Genie MAX Large Bore Introducer Sheath (🚀): Cleared for cardiovascular use, the Genie MAX Large Bore Introducer Sheath provides a temporary access pathway into large blood vessels, enabling the passage of balloons, stents, and clot removal systems while minimizing vessel trauma. Designed to support complex vascular interventions where controlled access is critical. genievascular.com
• Medela, LLC — Pump In Style® Pro+: Cleared within obstetrics and gynecology, the Pump In Style® Pro+ breast pump emphasizes steady suction control and user comfort. The system supports consistent milk expression while reducing operational noise and simplifying daily use for parents.
• Maquet GmbH (Getinge Group) — GSS67N Series Steam Sterilizer: Cleared for general hospital use, the GSS67N Series Steam Sterilizer supports sterile processing of surgical instruments and equipment. The system uses clean steam technology and integrated controls to support infection prevention and operational efficiency in hospital settings.

Explore the full list of this week’s clearances on the 510(k) Roundup page.

📋 Regulatory Roundup

January 26, 2026 Issue | By Martin King

This week’s regulatory activity reflects coordinated global movement across four themes highlighted by Martin King: resilience, reliance, rationalisation, and realignment. Regulators are strengthening safety and oversight, expanding reliance and convergence pathways, streamlining regulatory systems, and adjusting frameworks for AI, data, and innovation, with updates from the 📌 Central Drugs Standard Control Organization, 📌 Egyptian Drug Authority, 📌 European Commission, 📌European Medicines Agency, 📌 European Directorate for the Quality of Medicines & HealthCare (EDQM), 📌 Council of Europe, 📌 Health Canada | Santé Canada, 📌 Health Products Regulatory Authority (HPRA), 📌 Health Sciences Authority, 📌 MedTech Europe, 📌 UK Department of Health and Social Care, Ministry of Health New Zealand, 📌 Medicines and Healthcare products Regulatory Agency (MHRA), 📌 Swissmedic, 📌 Therapeutic Goods Administration (TGA), and the 📌 U.S. Food and Drug Administration (FDA).

Explore the Issue >>

In Case You Missed It

Wednesday, January 28, 2026 | 10:00 AM ET / 4:00 PM CET — Real-Life PMCF: Practical Lessons and 2026 Priorities, featuring subject matter experts Daniela Karrer and Matteo Mosso (Donawa Lifescience), with Diane Legere(DNV), focusing on how PMCF is applied in practice under MDR, including framing PMCF questions, selecting proportionate methods, and linking PMCF activities to CER updates and PSUR cycles, with reflections on current MDR revision work and notified body expectations. Watch the replay >>

🔥 Postscript

Did you know you can watch all our MLV Webinar Replays and Friday In-Focus Calls on our YouTube Channels?

- Sean 🐝