13/05
18:30 - 22:00
Pátio da Galé

Welcome Cocktail Reception at the Pátio da Galé

Welcome Cocktail

We are very pleased to welcome you to Lisbon and to Pátio da Galé, the chosen venue for the Medtech Forum Welcome Reception.
Located in one of Europe's largest squares, Pátio da Galé was once part of the Royal Palace, blending rich history with modern elegance.
With its grand arcades, open-air courtyards, and views of the Tagus river, Pátio da Galé is truly a unique location for cultural exhibitions or corporate events.

Directions: Praça do Comércio, 1100 Lisbon, Portugal
 

14/05
8:30 - 9:00
Exhibition Area

Welcome coffee

Welcome coffee

14/05
9:00 - 9:25
Auditorium I

Opening Keynote

Plenary session

More details to follow

14/05
9:25 - 9:50
Auditorium I

Keynote Conversation: Leading Through Uncertainty: Navigating Geopolitical and Economic Shifts

Plenary session

Explore insights into the geopolitical and macroeconomic shifts that are causing uncertainty for businesses and gain perspectives on how leaders can navigate this period.

14/05
10:00 - 10:50
Auditorium I

AI Unleashed: Strengthening MedTech Competitiveness in a New Industrial Age

Sponsored session

Explore how AI accelerates MedTech innovation and revenue in Europe’s complex healthcare. We’ll share real-world strategies to tackle regulatory, sales, market access, and cybersecurity hurdles, while respecting healthcare’s human core. Join us to unlock AI’s power in the new industrial revolution.

14/05
10:00 - 10:50
Auditorium II

MedTech Policy Trends: Navigating a Changing Geopolitical Landscape

Parallel session

An insightful session exploring how the evolving geopolitical landscape – the 2024-2029 EU mandate, as well as looking West (the US) and East (China and India) – is shaping the future of the medtech sector. Dive into the opportunities and risks emerging in this dynamic environment and discover how our industry can adapt and thrive.

14/05
10:00 - 10:50
Room A

Future of business interaction: How digital solutions are rewriting the commercial playbook in MedTech

Sponsored session

The MedTech industry is shifting towards digital solutions. Healthcare providers seek intelligent, scalable tools and services that leverage innovative tech to improve patient outcomes. Join industry voices to explore opportunities and tensions in this new commercial landscape.

14/05
10:00 - 10:50
Room B

Resilient Procurement, Stronger Healthcare: The ProCure Results

Parallel session

This session will present the final results of the ambitious EU ProCure project aiming to make current public procurement practices on medtech more resilient and efficient all over the EU, and to ensure that public health systems are ready for whatever crises the future brings.

14/05
10:00 - 10:50
Auditorium III

MedTech Meets Social Media: EU Compliance Update

Ask the expert

Recent EU enforcement updates highlight increased regulatory scrutiny over how medical device companies interact with healthcare professionals (HCPs) and promote their products on social media – This session will provide some tools to mitigate risks and avoid enforcement actions at the EU Member State level
 

14/05
11:00 - 11:50
Auditorium I

Boosting EU's competitiveness for MedTech innovation

Parallel session

Empowering patients, inspiring innovation! Europe is attractive for its innovative research ecosystem, accessible healthcare system and growing efforts towards value-based healthcare. However, action is needed to retain its historic place as global ‘epicenter’ of medtech innovation. Let’s discuss!

14/05
11:00 - 11:50
Auditorium II

Transforming Healthcare Beyond Hospital Walls

Parallel session

Outside-of-hospital and hybrid care models have proved their ability to improve patient outcomes, increase access, and reduce the burden on hospitals and healthcare systems. The session will address the healthcare providers' point of view and practical industry initiatives to scale up these models.

14/05
11:00 - 11:50
Room A

The AI Edge in MedTech Commercial—Insights from BCG’s 4th Milkman Study

Sponsored session

Join us as we unveil BCG’s latest ‘Milkman’ Commercial Benchmarking Study, offering fresh insights into the evolution of MedTech commercial models. With Qiagen’s Thorsten Harzer, we will explore real-world AI in action and share practical steps toward AI-enabled commercial model transformation.

14/05
11:00 - 11:50
Room B

Paving the Way for the European Health Data Space: From Policy to Practice

Parallel session

As the EHDS transitions from policymaking to practical implementation, this session brings together key stakeholders to discuss strategies, challenges, and best practices for its implementation. Panelists will highlight essential factors that accelerate adoption and help realize the full potential of the EHDS.
 

14/05
11:00 - 11:50
Auditorium III

Status of digital health reimbursement in the US and European Markets

Ask the expert

Join market access experts Meike Bomhof and Stephen Hull to explore digital health reimbursement in the USA, UK, France, Germany, and the Netherlands. Get updates on policies, coding, and payer evidence needs for AI, remote monitoring, and robotic tech across hospitals, data centers, and homes.
 

14/05
11:50 - 12:20
Exhibition Area

Networking break

Networking break

14/05
12:20 - 13:10
Auditorium I

From Evaluation to Action: The Future of MDR and IVDR

Parallel session

As we approach the 8th birthday of the MDR and IVDR and take stock of their targeted evaluation, this timely discussion will examine the consensus between actors and stakeholders for short-term solutions, including implementing acts, and the long-term vision for sustainable regulatory improvements.

14/05
12:20 - 13:10
Auditorium II

Cancer patient journey how MedTech fosters better and safer care

Parallel session

Medical technologies directly affect patient life and are essential for health care professionals in working side by side for cancer prevention, early detection, diagnosis and efficient and safe patient care. In this panel, stakeholders discuss and suggest on how optimizing medtech solutions enables better patient care, accelerates precision oncology and ensures patient safety. 

14/05
12:20 - 13:10
Room A

From Hype to Reality: Unlocking AI’s Potential in Medical Devices

Sponsored session

AI offers immense potential for medical devices, from early disease detection to robotic surgery. Yet, clinical deployment remains challenging. This talk explores how best practices, risk-based approaches, and regulatory alignment can unlock AI’s benefits while ensuring safety and reliability.

14/05
12:20 - 13:10
Room B

Navigating global business challenges in MedTech Operations to provide consistent patient care

Sponsored session

In today’s landscape, healthcare organizations face unique challenges, such as evolving trade policies, supply chain disruptions, technology advancements and global market expansion. Industry leaders will discuss strategies and insights for designing MedTech operations that address these challenges and ensure seamless global patient care.

14/05
12:20 - 13:10
Auditorium III

AI-Driven Translation in MedTech: The power of Quality Estimation and Human Expertise

Ask the expert

Discover how AI-driven translation technology is transforming the Medical Devices industry by ensuring compliance and efficiency. This session explores AI-powered machine translation, automatic quality estimation (AQE), and expert post-editing. Learn how glossaries, quality frameworks, and AI optimize workflows with real-world case studies.

14/05
13:10 - 14:10
Exhibition Area

Networking lunch

Networking lunch

14/05
14:10 - 15:00
Auditorium I

Safe AI, Smarter Care: Transforming European Healthcare Systems

Parallel session

The panel seeks to bring together stakeholders from across the healthcare ecosystem to discuss how the safe uptake of AI can revolutionise healthcare delivery in Europe.
The panel will gather experts from hospitals, healthcare professionals, industry and academia to provide for a multi-perspective discussion.
 

14/05
14:10 - 15:00
Auditorium II

Empowering European Innovators With Early Feasibility Studies

Parallel session

HEU-EFS is an IHI project wich aims at developing an EU harmonised framework to improve the uptake of Early Feasibility Studies (EFS) for medical devices in the European Union. EFS are a crucial part of the evidence-generation cycle for medical devices. Conducting these studies in a coordinated manner across Europe will bring significant benefits to patients, innovators, and the entire healthcare system.

 

14/05
14:10 - 15:00
Room A

UK - EU: Ready for a Reset?

Parallel session

A reset in the relationship between the UK and the EU is underway, with agreement that leaders will meet in an EU-UK Summit. What can realistically be expected from the reset and what it could imply for market access for medical technologies? This session will explore the current market access environment in the UK and what opportunities the reset of the bilateral relations could bring for the medtech industry.

14/05
14:10 - 15:00
Room B

From Data to Diagnosis: Digital Tools Transforming Diagnostics

Parallel session

Join us to explore the transformative potential of digital solutions in the IVD sector for clinical evidence generation. These technologies enable efficient data collection, analysis, and validation, improving diagnostic accuracy and supporting personalized medicine. Let’s discuss how MedTech Europe members can shape these trends.
 

14/05
14:10 - 15:00
Auditorium III

Are You Winning or Losing Market Share? The Value of Precise Market Data

Ask the expert

Ask the expert session on MTE's flagship publication and golden standard data trackers. The place to ask direct questions comming from all type of data users and stakeholders. Explore the value of precise, actionable market data in shaping business strategies. Learn how MedTech Europe's data services provide companies with the tool to uncover trends, benchmark performance, and identify growth opportunities.

14/05
15:10 - 16:00
Auditorium I

Climate meets Economics: Bridging Green Goals and Competitive Edge in Healthcare

Parallel session

Are decarbonisation and competitiveness friends or foe? Do the Draghi Report and EU Clean Industrial Deal deliver for MedTech? How to leverage the power of medtech for healthcare system transformation and competitiveness?
 

14/05
15:10 - 16:00
Auditorium II

HTAR in Medical Devices - Boosting or Stifling Innovation in Europe

Parallel session

Boosting or stifling innovation in Europe? This session will provide timely insights on the status of implementation of the Health Technology Assessment Regulation (HTAR) four months after its date of application with a focus on its impact on the availability of innovation in Europe.

14/05
15:10 - 16:00
Room A

Shaping the Future of Clinical Investigations in Europe

Parallel session

In light of the pilot coordinated assessment for clinical investigations of medical devices (MDR Art.78) which has been launched in early February by the Member States and the European Commission, this session will take stock of the process so far, clarify the possibilities offered to sponsors by this pilot and answer any remaining questions. The session will also look to the future at next steps.
 

14/05
15:10 - 16:00
Room B

EU and MDSAP - a Dream or a Viable Opportunity?

Parallel session

The Medical Device Single Audit Program (MDSAP) is arguably the landmark example of international regulatory cooperation. Learn why it is so timely for the EU to join it as a full member, accelerating European patients’ access to medical technologies and fostering EU’s competitiveness and innovation.

14/05
15:10 - 16:00
Auditorium III

Navigating U.S. Anti-bribery compliance under the Trump Administration

Ask the expert

This session focuses on how multinational companies can manage risk related to the U.S. Anti-Kickback Statute, False Claims Act, and Foreign Corrupt Practices Act in light of the changing priorities under the Trump Administration, and how understanding U.S. enforcement activity can help companies prepare for how similar trends may play out in Europe.

14/05
16:00 - 16:30
Exhibition Area

Networking break

Networking break

14/05
16:30 - 17:20
Auditorium I

Navigating Sustainable Corporate Governance: Challenges and Opportunities

Parallel session

Join us for a session on implementing the CSRD and CSDDD in MedTech. Explore challenges, opportunities, and potential changes amid economic and global competition. Gain insights on staying ahead in sustainability while remaining competitive. Engage with experts on the future of sustainable corporate governance.

14/05
16:30 - 17:20
Auditorium II

What If We Designed Healthcare for Women?

Parallel session

Challenging the systems, science, and silence that have failed women: thought leaders explore how medtech can advance diagnostics, personalized care, reproductive health, and gender equity—driving solutions through collaboration.
 

14/05
16:30 - 17:20
Room A

EUDAMED: The Central Approach for Gathering Data on Medical Devices

Parallel session

The European Medical Device Database EUDAMED will become the mandatory IT system to use for the MDR and IVDR in only 6 months’ time after this session. What changes and new considerations will this central approach bring to manufacturers and other users in data submission and data access?

14/05
16:30 - 17:20
Auditorium III

The US Regulatory Landscape – Making Sense of the Current Chaos

Ask the expert

Between staff reductions, executive orders, and tariffs, it has been a tumultuous time at the FDA. In this session, hear the key initiatives impacting the US FDA are and how these could affect the regulation of medical devices in the US. Discuss best practices to continue doing business in the US.

14/05
17:30 - 18:10
Auditorium I

Pioneering Fusion Research – Insights from the Champalimaud Foundation

Plenary session


In her keynote address Leonor Beleza will introduce the pioneering work of the Champalimaud Foundation and its distinctive concept of fusion research—an integrated model that unites advanced biomedical research with translational, interdisciplinary clinical care.
Her remarks will highlight the Foundation’s commitment to innovation, scientific excellence, and sustainability in healthcare, offering a source of inspiration for those shaping the future of care. Drawing from her extensive career, Leonor Beleza will share key reflections on leadership, research-driven impact, and the evolving role of global collaboration in healthcare advancement.
The keynote will be followed by a fireside chat with Oliver Bisazza, providing further perspectives on the Foundation’s mission and the broader implications of its work for the medical technology and research communities.
 

14/05
18:10 - 19:40
Exhibition Area

Networking reception

Networking cocktail

15/05
8:00 - 8:30
Exhibition Area

Welcome coffee

Welcome coffee

15/05
8:30 - 9:20
Auditorium I

CEO #nofilter

Plenary session

A high-level discussion with executives from four leading companies on trends and key issues, including priorities in serving patients and customers, how to speed up care pathways, navigating the European regulatory landscape, encouraging investment in innovation and how to attract top talent.

 

15/05
9:30 - 10:20
Auditorium I

Why Europe Matters: Exploring MedTech Investment Potential

Parallel session

How can Europe remain an attractive destination for MedTech investments? Hear from top investors as they explore the sector’s potential and what it needs to thrive in a competitive global market.

15/05
9:30 - 10:20
Auditorium II

Driving secure health data access via the IDERHA IHI Project

Parallel session

The IDERHA (http://www.iderha.org/) consortium will create a federated data space for secure health data access and develop policy recommendations for RWE acceptance in regulatory decision making. The panel will explore the importance and opportunities of health data access to enable innovative healthcare solutions.
 

15/05
9:30 - 10:20
Room A

Protecting Privacy in the Age of AI-Powered Healthcare

Parallel session

Delve into the critical role of privacy in the rapidly evolving landscape of AI-driven healthcare. This session will explore the intersection of cutting-edge digital health innovations and robust privacy frameworks, including the EU AI Act and GDPR. Learn how to implement ethical AI practices to build trust and drive compliant innovation.

15/05
9:30 - 10:20
Room B

Secure and Seamless: The Next Generation of Technical Documentation

Parallel session

This panel will delve into modernising Technical Documentation through a harmonised, item-level approach, enabling secure, system-agnostic data exchange with standardised formats and nomenclature. The discussion will highlight the importance of supporting SMEs by removing financial barriers, while preserving flexibility for manufacturers, paving the way for sustainable and forward-thinking regulatory practices.

15/05
9:30 - 10:20
Auditorium III

Innovative Payment Schemes – Lessons Learned from Pharma and Medical (Digital) Devices

Ask the expert

Discover how payers are rethinking payment models and accelerating access to innovation. Backed by HI-PRIX findings, this session explores the strategies shaping the future of healthcare financing.
 

15/05
10:20 - 10:50
Exhibition Area

Networking break

Networking break

15/05
10:50 - 11:40
Auditorium I

Re-imagining Cyber Secure Health

Parallel session

Multistakeholder panel discussion: representatives from hospitals, industry and regulators will debate cybersecurity in healthcare, aiming to share best practices and insights on how to re-imagine the health ecosystem to make sure it is cybersecure.

15/05
10:50 - 11:40
Auditorium II

Navigating Litigation: Securing MedTech’s Future in Europe

Parallel session

Explore Europe's evolving litigation landscape, from class actions under the Representative Actions Directive to the impact of Third Party Litigation Funding. Learn proactive strategies to navigate these challenges and ensure resilience in a rapidly changing legal environment.

15/05
10:50 - 11:40
Room A

Global Market Focus: Brazil

Parallel session

Brazil is projected a solid growth of medical technology market over the next five years. Its evolving healthcare market, particularly for innovative technologies presents a wealth of opportunities for medtech manufacturers. In this session, experts will explore the trends and policies driving the growth of the medtech market, discuss the challenges and opportunities and what it takes to succeed in Brazil.

15/05
10:50 - 11:40
Room B

Aligning PLM & QMS Processes for MedTech Excellence

Sponsored session

Unlocking product lifecycle excellence starts with aligning PLM and QMS. Learn how MedTech companies streamline operations, enhance product integrity, and accelerate time-to-market with a process-first approach balancing innovation, safety, and efficiency.

15/05
10:50 - 11:40
Auditorium III

Everything You Wanted To Know About IHI (But Were Afraid To Ask)

Ask the expert

IKOP, IKAA, Financial Contribution, 3A? If it does not ring a bell, join this session! IHI projects offer many benefits such as funding and networking, to name a few. People participating in the first projects will highlight why they have joined this public-private partnership on health innovation.

15/05
11:50 - 12:40
Auditorium I

Implementing the EU Green Deal in Healthcare

Parallel session

Tackling Challenges, Seizing Opportunities - How is the medical technology sector navigating the Green Deal maze? How to connect sustainability dots for better health and patient outcome? What’s coming next?

 

15/05
11:50 - 12:40
Auditorium II

Closing the Loop: Turning Customer Insights Into Product Excellence

Sponsored session

Join us to explore the transformative potential of digital solutions and AI for enhanced product performance, customer experience, safety, and post-market surveillance. Discover impactful projects and discuss how the MedTech Industry can shape these trends.

15/05
11:50 - 12:40
Room A

Advancing the Assessment of Digital Health to Foster Innovation

Parallel session

The focus of this session will be to shine a spotlight on EU-level initiatives currently supporting the development of inclusive and fit-for-purpose European assessment frameworks for digital health technologies. Understanding the interplay between different initiatives and their potential to be effectively applied in practice is expected to advance the assessment of digital health to foster timely access to innovation for European patients.

15/05
11:50 - 12:40
Room B

Shaping the Future of Wound Care

Parallel session

The session will examine the burden of wounds on the healthcare systems and policy trends impacting wound management. How better wound care policy can address inequalities in healthcare and drive sustainable healthcare.

15/05
11:50 - 12:40
Auditorium III

How AI & PLM Drive Smarter Compliance in MedTech

Ask the expert

MedTech companies face rising pressure from fast-evolving global rules. Join Deloitte & PTC to see how AI and PLM turn compliance into an asset - enabling smarter decisions, continuous monitoring, and full lifecycle coverage. Move from caution to confidence.

15/05
12:40 - 13:40
Exhibition Area

Networking lunch

Networking lunch

15/05
13:40 - 14:30
Auditorium I

Innovating for Planetary and Human Health: Sustainability Trends at Global Level

Parallel session

Environmental challenges do not halt at national or regional level while supply chains in the medical technology sector are globally intertwined. As many governments are looking to advance sustainability in the healthcare sector, this session aims at providing a snapshot of common trends.
 

15/05
13:40 - 14:30
Auditorium II

Cutting Edge: The future of Robotic Surgery

Parallel session

The value of Robotic-assisted surgery (RAS) will be the centre of the discussions among experts and stakeholder organisations. Speakers will evaluate the unmet healthcare needs of European citizens and discuss strategic policy initiatives to address them.

15/05
13:40 - 14:30
Room A

A New Cardiovascular Health Plan for Europe, a Game Changer for Patients

Parallel session

The session will be entitled “A new Cardiovascular Health Plan for Europe, a game changer for patients”, and will bring together key representatives from the cardiovascular community, patient organizations, industry, and policymakers. The discussion will explore how to accelerate early detection, innovation, and equitable access to treatment, and how these elements can be integrated into the upcoming EU Cardiovascular Health Plan

15/05
13:40 - 14:30
Room B

Fast-track health technology assessment for in vitro diagnostics

Parallel session

The evolution of in vitro diagnostics (IVDs) underscores the need for an optimized health technology assessment (HTA) framework. A BMJ Innovations study used design thinking to engage stakeholders, proposing a fast-track HTA system to enhance IVD evaluation, adoption, and healthcare efficiency.

15/05
13:40 - 14:30
Auditorium III

Unlocking Health Data: The EU Data Act's Impact on Digital Health

Ask the expert

The EU Data Act aims to foster fair and secure data sharing across the EU. It will affect any connected medical device or health wearable that generates or collects data from its users and where those services are supported by the cloud, could implicate cloud portability requirements under the Act. In this presentation, we will explore the main features and implications of the Data Act for the digital health sector, as well as the key issues and challenges that need to be addressed, such as deadlines, obligations towards patients/users, compliance requirements.
 

15/05
14:40 - 15:30
Auditorium I

The MDR/IVDR 5-year recertification: Urgent question, strategic choices

Parallel session

As MDR and IVDR certificates near expiry, a system-wide bottleneck looms. Can the current framework withstand the pressure, or are we heading toward gaps in patient access to life saving devices? This high-level panel explores the strategic and urgent questions behind the 5-year recertification cycle, at the heart of the EU’s ongoing regulatory evaluation.

15/05
14:40 - 15:30
Auditorium II

Engaging with Impact: Stories of MedTech and Patient Collaboration

Parallel session

This plenary session highlights powerful examples of how medtech companies are engaging with patients and patient associations to drive innovation and improve outcomes. Hear firsthand from company representatives and patient advocates as they share their stories, challenges, and the power of working together to shape a patient-centered future.
 

15/05
14:40 - 15:30
Room A

Navigating Interoperability in the EHDS: Roles and Responsibilities for Manufacturers

Parallel session

This session explores new interoperability requirements introduced by the EHDS, examining their impact on digital health solutions and medical technologies, and highlighting the importance of collaboration with standards organizations such as IHE to ensure seamless interoperability in this new health data ecosystem.

15/05
14:40 - 15:30
Room B

Assess your internal readiness for Value-Based Healthcare

Parallel session

This session will introduce a self-assessment tool for medical technology suppliers to assess their internal readiness, to engage with Value-Based Healthcare systems co-developed by prof. Laing (Swansea University) and a MedTech Europe ad hoc working group

15/05
14:40 - 15:30
Auditorium III

HERA in Action: Readiness for an Unpredictable World

Ask the expert

Preparedness became a buzzword in the healthcare sector in 2025. In this session HERA delegate will explain how the EU is getting ready to act in the face of a public health crisis. You will learn about the preparedness priorities, what may be required of our sector and how you can benefit from it.
 

15/05
15:40 - 16:00
Auditorium I

Conclusions

Plenary session

- PAST SESSIONS -