regularia 2026 – Program Overview
08:30
Registration – Entrance Foyer
09:00
Coffee Talks / Exhibition
10:00
Welcome (Blue Stage): Julia Steckeler, Managing Director, MedicalMountains GmbH
10:15
Opening Address & Key Talk (Blue Stage): Nina Warken, Federal Minister of Health
11:00
Expert Talks (Blue Stage / Green Stage)
BLUE STAGE: MDR
- Lean Change Management Under the EU MDR: Ensuring Compliance and Efficiency
- Mastering EUDAMED UDI Registration – Where to Start & How to Overcome Uncertainty?
- Time Is Relative: PSURs Between Regulatory Expectations and Practical Digital Implementation
- Clinical Safety Without Clinical Data – The Exception or Not So Rare After All?
GREEN STAGE: Material Compliance
- From Regulation to Resilience: Securing Market Position and Success Through Sustainability & Compliance
- PFAS Restriction: A Challenge for Industry and Patient Care
- Upcoming Changes to ISO 10993-1: An Overview of the Draft
- New Test Methods for Microplastics in Medical Devices and Impacts on Existing Standards
12:00
Lunch Talks / Exhibition Europe IT
Booth 12 / Entrance Area : MDR / EUDAMED-UDI
Booth 12 / Entrance Area : MDR / EUDAMED-UDI
13:00
Expert Talks (Blue Stage / Green Stage)
BLUE STAGE: Digitalization of RA & QM
- Rethinking RA Processes: Using Digital Tools and a Unified Data Model to Move Efficiently into the Future
- Simple Digitalization of the Manual Shopfloor – With Measurable Added Value
- Digitizing Documentation: A Must in RA, QM, TD. A Practical Example
- AI-Supported Identification and Analysis of Regulatory Changes
GREEN STAGE: Sustainability / Green Deal
- Green Deal – The EU’s Sustainability Legislation and Its Impact on the Medical Device Sector
- More Revenue, Strong Customer Loyalty, Top Talent: Sustainability as a Business Case for MedTech SMEs
- Our Path to Sustainability
- And Suddenly Battery Manufacturers?! – The Battery Regulation Explained for MedTech, Concisely
14:00
Coffee Talks / Exhibition Europe IT
Booth 12 / Entrance Area : Digitalization RA/QM
Booth 12 / Entrance Area : Digitalization RA/QM
15:00
Expert Talks (Blue Stage / Green Stage)
BLUE STAGE: International Market Authorization
- International QSV – US QMSR Harmonization: Leverage Benefits, Identify Risks, Avoid Problems
- Regulatory Go to Market Strategy for the USA in Uncertain Times
- UKCA, UKRP, MDR – What Applies to Whom, and For How Long? UK Overview
- Saudi Medical Device Law – A Stiff Breeze for Manufacturers?
GREEN STAGE: Cyber Security / Software / AI Act
- AI-Based Medical Devices in 2025 – Practical Experience from a Notified Body
- Navigating the Regulatory Tension Between the AI Act and the MDR
- Myth of the Black Box? Validating and Approving Language Models Safely in MedTech
- Risk Management Alone Is Not Enough – Cybersecurity in Focus
- PLD Meets MDR: New Product Liability and Strategies for Medical Devices in the Digital Age
16:00
Coffee Talks / Exhibition Europe IT
Booth 12 / Entrance Area : International UDI
Booth 12 / Entrance Area : International UDI
16:30
Panel Talk (Blue Stage)
17:30
Get-together
Europe IT Consulting Solutions at regularia
UDI transmission as a service or SAP add-on – incl. validation, submission, and proof.