Global leaders from the field of medical devices, diagnostics and digital health will join the discussion and speak openly about the latest trends, challenges and opportunities they are facing.

The proposed European Health Data Space (EHDS) is a cross-cutting legislative file and Europe’s vision for the future of health. It has the goal to empower citizens and patients through more accessible electronic health data and enhancement of health data sharing. At the same time, the EU aims to enhance the availability of data to support research for much-needed innovation in the health sector. The EHDS has the potential to revolutionise healthcare to a deeper pool of EU-wide health data and unlock significant tech, AI and data analytics innovation.
To a certain extent, the future is already a reality, and we can get an idea of what could be possible if we extend the use of real-world data for research and innovation. This session brings us back to the future to highlight stories which underline the need for health data sharing and show the crucial benefits for patients, healthcare professionals and health systems by sharing their stories.

Digital health solutions generate vast amounts of data, which will continue rapidly increasing. Real-world data (RWD) can be routinely collected in real-world settings and used and analysed to generate real-world evidence (RWE). The potential usage of RWE and its effects in healthcare is immense. By fully acknowledging and utilising these data, reliable RWE for policymakers, payers, and medtech manufacturers can be effectively considered in decision-making for health economic evaluation, reimbursement, funding, and the improvement of health outcomes overall. However, fragmentation among different stakeholders and their willingness to use RWE for decision-making is a barrier to their wider use. How can healthcare systems fully recognise and harness the value of RWE for quicker assessment and market access of medical technologies?

In Europe, reimbursement and funding of medical procedures and technologies are conceived and provided independently by each country. Each has its own system resulting from its particular political, administrative, and constitutional structure. This situation has led, amongst other things, to a significant disparity across European countries in the number and use of pathways that enable timely market access to innovative digital health technologies, medical devices, in vitro diagnostics, and medical procedures. Up to now, only a limited number of European countries have implemented coverage streams for promising innovative medical procedures and technologies. Similarly, only a limited number of countries are conducting concrete political initiatives to transform their healthcare and/or reimbursement and funding systems.

Join this session to discover the frontrunners in terms of pathways, to which technologies these pathways apply, who can apply for them and if they are being used in practice. Some of the main conclusions of MedTech Europe - MTRC 2022 project “Mapping the pathways enabling market access to innovative medical procedures and technologies” will be revealed.

In November 2022, the EU Agency for Cybersecurity (ENISA) published the 2022 Cybersecurity Threat Landscape. The report follows the European Commission’s proposed Cyber Resilience Act, a regulation aimed at shoring up the cybersecurity of connected digital products. This case reflects a trend of legislative interventions reinforcing the European digital space. However, recent cybersecurity breaches (including notorious cyberattacks on the Irish Department of Health and the Health Service Executive) show that European healthcare systems remain dangerously exposed to the evolving threat landscape. This session aims to discuss the European cybersecurity threat landscape, particularly in relation to health, including possible legislative and non-legislative methods to bolster the security, safety and trust of healthcare delivery.

There is one year left until the central medical device database, EUDAMED, becomes fully functional. The session provides you with valuable considerations on how to prepare for full compliance with the database. Will EUDAMED affect Vigilance and Post-market Surveillance? Does it have any consequences for Clinical Investigations and Performance Studies? How can you plan the resources needed to interact with EUDAMED? Find out with us.

Ireland is home to some of the most remarkable medtech start-ups in the world. Ireland’s indigenous life sciences start-ups grew from a wealth of multinational experience. Four Irish start-ups have been selected based on their innovation in health and creating medtech solutions focusing on various issues, from diseases with unmet needs to digital health platforms.

The medtech industry, like others, has thrown resources at GDPR compliance, but despite the wealth of experts and compliance systems is the truth that total compliance is impossible, in particular for medtech organizations, which have complex data needs. Has Europe achieved the privacy objective?

The transition to the EU MDR and IVDR will have an impact on access to markets around the world. The concept of CE-marking, well established in the EU, is used in many countries outside Europe to support medical devices’ registrations. This session will address the global impact of the EU regulations and solutions to maintain access to international markets. Join us for an exciting panel discussion to explore how leading medtech manufacturers are managing the impact on their international registrations and addressing the questions posed by regulatory authorities outside the EU.

This session will consider where we can increase Notified Body capacity to support the implementation of the IVD Regulation system. Can we simplify the complexity and reduce the time of conformity assessment and other major Notified Body activities? What role should regulators, Notified Bodies, manufacturers and other stakeholders play?

Artificial Intelligence (AI) in healthcare holds the promise to improve patient outcomes and healthcare systems. It can also tackle many healthcare challenges, including workforce shortages, healthcare financing and improving or even saving patients’ lives. With the launch of the AI Act, the EU has the potential to lead this area by building an advanced and fit-for-purpose regulatory environment and ensuring greater patient trust. While the proposed legislation will determine how and if new AI-enabled medical technologies will be placed on the market and reach patients, it begs the question of where AI-enabled medical technology is actually changing healthcare for the better on the ground and if the AI Act would become a hurdle or accelerator to the transformation.

The proposed European Health Data Space (EHDS) is a top priority for the European Union and the medical technology industry active in Europe. It promises better availability and exchange of electronic health data and provides the opportunity to introduce common standards. This legislation would help facilitate an environment that empowers the medical technology industry and other communities, such as research and patients. However, to ensure the EHDS fulfils its promise to allow seamless data flow, we need to remove obstacles to interoperability. The lack of interoperability can result in an incomplete understanding of an individual’s or population’s health needs, which can lead to poorer outcomes and higher costs from different perspectives

The current wave of regulatory activity at European level is creating a perfect storm that is causing Europe to sleepwalk towards a US-like litigation culture. A sharpening of liability laws, with the proposed drafts revising the Product Liability Directive and the AI Liability Directive strongly tipping in favour of consumers. The (uncoordinated) tightening of screws around horizontal and vertical safety regulations. The introduction of pan-European class actions and, last but not least, litigation funders are opening shops in several EU Members States incentivising a different consumer behaviour. These processes will result in an unavoidable increase in claims. The panel will discuss these developments and address what can still be done or should be done to avoid a US-like litigation culture coming to Europe.

The Innovative Health Initiative (IHI) is the EU’s €2.4 billion public-private partnership to create an innovation ecosystem that facilitates the translation of scientific knowledge into tangible innovations. IHI implemented the first wave of consortia in 2023 and will continuously launch calls until 2027. Its mission is to bring together diverse academic and other public stakeholders for collaborative high-impact health projects with the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area. This session will focus on how medical technology companies can shape and join projects under IHI and share the experience of the IHI pioneers made at different stages of building IHI partnerships.

Recent events have shown that medical devices are extremely susceptible to disruptions in their supply chain. Medical devices are subject to strict regulatory requirements and at most times, supply chain disruptions are also going to have a regulatory impact. Manufacturers have had to deal with a fair share of supply chain challenges over the past three years. Shortages of key raw materials, logistics delays, sterilization constraints, labour challenges, the list goes on resulting in skyrocketing costs and delays. This session will explore how policy makers and manufacturers are dealing with the continuous and emerging supply chain challenges and how to increase the resilience of supply chains to withstand the future disruptions.

Global leaders from the field of medical devices, diagnostics and digital health will join the discussion and speak openly about the latest trends, challenges and opportunities they are facing.