Save the Date: regularia 2026

Save the date: regularia 2026 – Europe IT Consulting will be there

On 3 March 2026, the regularia will take place for the first time at Stadthalle Tuttlingen – the new regulatory forum for the medical technology sector. The event brings together experts and decision-makers from regulatory affairs, quality management, politics and industry to discuss practical solutions for MDR, international approvals, the AI Act, material compliance and sustainability. Europe IT Consulting will be present on site as an exhibitor.

What is regularia?

regularia is organised by MedicalMountains in Tuttlingen and is establishing itself as a central regulatory forum for the medical technology industry.

The full-day programme on 03.03.2026 at Stadthalle Tuttlingen offers:

Welcome address by MedicalMountains
Ceremonial opening by the Federal Minister of Health
Several parallel specialist sessions on two stages
Final panel discussion with representatives from politics and industry

Target group:

Managing directors and executives
Specialists and managers from regulatory affairs, quality management and related areas
Service providers, laboratories and notified bodies (accompanying exhibition)

Key topics of regularia 2026

The published programme is divided into several topic blocks on two stages (“Blue Stage” and “Green Stage”):

MDR & clinical requirements
- Experience with implementing the MDR in daily practice
- EUDAMED registration and handling uncertainties
- PSURs between regulatory expectations and practical implementation
- Clinical evaluation and safety with limited clinical data

Digitalisation of RA and QM
- Redesign of RA processes with digital tools
- Digitalisation of manual processes on the shop floor
- Digital documentation in RA, QM and engineering
- AI-supported identification and analysis of regulatory changes

International approvals
- Harmonisation of US quality requirements (e.g. QMSR)
- Go-to-market strategies for the USA in uncertain times
- Overview of UKCA, UKRP and MDR in the United Kingdom
- Insights into medical device legislation, e.g. in Saudi Arabia

Material compliance & sustainability / Green Deal
- Sustainability and compliance as a strategic competitive factor
- PFAS restrictions and their impact on industry and supply chains
- Changes to relevant standards (including biocompatibility, microplastics)
- EU Green Deal requirements and their concrete impact on MedTech companies
- Practical case studies on how MedTech SMEs implement sustainability
- Requirements of the Battery Regulation for medical devices

Cybersecurity / Software / AI Act
- Experience of a notified body with AI-based medical devices
- Interaction between the AI Act and the MDR
- Validation and approval of systems using language models
- Cybersecurity requirements beyond classic risk management
- Product liability issues in the digital environment

This means that regularia covers a broad spectrum – from classic MDR compliance and international markets to AI, cybersecurity and sustainability.

Why regularia is relevant for UDI and data owners

For many manufacturers, the period up to 2026 is characterised by:

EUDAMED implementation and increasing mandatory use,
Swissdamed UDI Devices and national specificities,
parallel requirements from FDA GUDID, UKCA and other markets,
as well as growing pressure to improve data quality, processes and automation.

This is precisely where Europe IT Consulting comes in with the Global UDI Data Management Solution (GUDI) and complementary services – from Excel templates and validation tools through to SAP-integrated UDI workflows.

regularia provides the ideal setting to:

get a concise overview of current regulatory developments,
take away best practices for UDI and digitalisation projects, and
discuss concrete questions with experts and service providers.

Meet us at regularia!

For our customers and partners, regularia is an ideal opportunity for a personal meeting. We are happy to schedule appointments around the event – directly in Tuttlingen or virtually afterwards – to discuss together: