Barcelona Health Hub member InnHealthium is bringing together experts in AI-enabled medical devices, standards development, QA/RA and conformity assessment for a dedicated event at Barcelona Health Hub on September 22, helping the MedTech ecosystem prepare for the practical impact of the EU AI Act.

As the EU AI Act moves from regulation to implementation, medical device manufacturers face an increasingly urgent question:

How can manufacturers demonstrate that their AI-enabled medical devices comply with the EU AI Act while some of the standards intended to support compliance are still being developed?

This is the challenge at the heart of “AI-Enabled Medical Devices: The EU AI Act Clock Is Ticking,” an in-person event organized by InnHealthium in collaboration with DEKRA and with DiarioSalud as Media Partner.

Taking place at Barcelona Health Hub on September 22, 2026, the event will give the BHH community and the wider MedTech ecosystem the opportunity to hear firsthand from experts working close to the evolving AI regulatory and standards landscape.

Bringing together standards, Notified Body and MedTech expertise

One of the key objectives of the event is to connect the regulatory requirements manufacturers already face with the standards and practical approaches that will help companies demonstrate compliance.

The session brings together three complementary perspectives:

Alexis Ruiz — AI Medical Expert at DEKRA

Ruiz will bring the perspective of a Notified Body, helping participants understand how AI-related requirements connect with conformity assessment and what manufacturers should be considering as they prepare AI-enabled medical devices for certification.

Enric Bargalló — AI Expert MedTech Consultant at InnHealthium

Bargalló will focus on the practical implications of the EU AI Act for MedTech companies and how manufacturers can begin translating emerging requirements into their product development, risk, data and regulatory strategies.

Celestina Bianco — Invited Speaker, with more than 25 years leading QA/RA for SaMD

Bianco brings extensive experience in Quality Assurance and Regulatory Affairs for Software as a Medical Device, providing a practical manufacturer-focused perspective on incorporating regulatory requirements into real-world development and quality processes.

The discussion will also address the evolving standards landscape, including IEC PAS 63621:2026, IEC CDV 63450 and prEN 18228, and what these developments could mean for manufacturers developing AI-enabled medical devices for the European market.

The challenge is moving from requirements to action

For MedTech companies, the question is no longer simply “What does the EU AI Act require?”

The more pressing challenge is:

“What should we be doing now to prepare?”

The requirements are taking shape, but the standards, methodologies and industry consensus around how manufacturers will demonstrate compliance continue to evolve.

This creates an important window for companies developing AI-enabled medical devices.

Decisions being made today around risk management, data, model evaluation, technical documentation and product architecture could directly affect a manufacturer’s ability to demonstrate compliance later.

For start-ups in particular, incorporating these considerations before a technical architecture becomes difficult and costly to modify can be critical. For more mature manufacturers, the challenge is identifying potential gaps early enough to address them before conformity assessment.

The September 22 session is designed to help manufacturers anticipate these issues and begin turning regulatory requirements into practical action.

An invitation to the Barcelona Health Hub community

As a member of Barcelona Health Hub, InnHealthium invites fellow BHH members and the wider Barcelona digital health and MedTech ecosystem to join the conversation.

The event will be particularly relevant for medical device manufacturers, MedTech and digital health companies, founders, executives, QA/RA professionals, AI and technical teams, and product leaders developing or planning to develop AI-enabled medical devices for the European market.

Participants will have the opportunity to learn directly from experts close to standards development and conformity assessment, ask questions, and better understand what their organizations should be considering today as the EU AI Act moves toward implementation.

AI-Enabled Medical Devices: The EU AI Act Clock Is Ticking

Date: September 22, 2026
Time: 3:00 PM
Location: Barcelona Health Hub, Barcelona
Organized by: InnHealthium
In collaboration with: DEKRA
Media Partner: DiarioSalud

Attendance is limited and registration requests are subject to approval.

Barcelona Health Hub members are invited to join InnHealthium, DEKRA and leading MedTech experts for a practical discussion on preparing AI-enabled medical devices for the EU AI Act.

Register now: innhealthium.com/event