Filters

04/05
09:00 - 09:30
Opening session


04/05
09:30 - 10:20
Plenary

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.

04/05
10:30 - 11:20
Parallel session

The IVD Regulation will fully apply in just 20 days after the MedTech Forum. Is the IVD sector prepared and will all diagnostics remain available to patients and healthcare systems? What are the main challenges for the new system which remain and how can these be addressed? It is expected that most IVDs will still need certification and that many implementation challenges will remain. How can all stakeholders ensure the long-term success of the new regulatory system?

04/05
10:30 - 11:20
Parallel session

Article 40 of the General Data Protection Regulation (GDPR) foresees the possibility for industry associations to prepare codes of conduct to specify the application of the GDPR. It can be used as a tool to demonstrate compliance with the GDPR while helping companies to fulfil the obligations imposed by the GDPR. The medtech industry includes companies with very different business models, which are diagnostics, medical devices and digital health companies.
The idea of the session is to explore whether a GDPR code of conduct could be realistic for the medtech industry, and if so, which topic(s) it should cover. Examples include the processing of personal data for research purposes or international personal data transfers. In addition, it will also focus on the challenges and lessons learned from other organisations in the process of developing GDPR codes of conduct.

04/05
10:30 - 11:20
Parallel session

The session will discuss how Value-based Procurement contributes to resilient and sustainable healthcare across Europe. Furthermore, it will highlight what is needed to reap the benefits of this innovative way of procuring and contracting from both a healthcare provider as well as a medtech industry perspective.

04/05
11:20 - 12:00
Networking break


04/05
12:00 - 12:50
Parallel session

The Innovative Health Initiative kicks off in January 2022. The objective of the €2.4 billion IHI partnership is to create an EU-wide health research and innovation ecosystem that facilitates the translation of scientific knowledge into tangible innovations. IHI brings together diverse stakeholders (universities, companies large and small, and other health stakeholders) in collaborative projects that address disease areas where there is a high burden on patients and/or society. In IHI cross-sectoral projects involve the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area.

04/05
12:00 - 12:50
Parallel session

The European Health Data Space reflects a compelling vision to integrate Europe’s national and regional health data systems. It has also put Europe’s national and regional health systems on the spot, and shown that there are significant variations in digitalisation as well as untapped data reservoirs and potentials for data transfers and use. This session will focus on the “nuts and bolts” of data use and re-use, and explore the efforts and resources still required to make the EHDS a reality.

04/05
12:00 - 12:50
Parallel session

Following several years of impasse, the member states - supported by the European Commission- proposed a new law, now accepted by the three European institutions. Driven by the member states and financed by the European Commision, joint work will be done on methodologies, scientific advice and assessments defined in an annual workplan. This new regulation will recognise the specificity of medical technologies and a dedicated governance is expected, but implementation over the next 3 years will define the true impact. The MedTech Forum Panel discussion brings together representatives of member states, of the newly formed heads of agencies group involved in HTA, of the European Commission, of the medical technology industry, and of patients to provide insight of the current line of thinking on what to expect in coming years of activities under this new regulation. A preferred way forward by MedTech Europe members will also be shared.

04/05
12:50 - 14:15
Networking lunch


04/05
14:15 - 15:05
Parallel session

Today it is already possible to register your company, economic operators and your products in the new centralised EU medical devices database, EUDAMED. However, EUDAMED exists today together with scattered national databases. It can be costly and confusing for manufacturers and other economic operators to navigate the EU 26 countries’ national notification and registration rules. What is the situation? Is there a solution and a possible way forward?

04/05
14:15 - 15:05
Parallel session

The medical technology industry is at the heart of the health data ecosystem, providing data that meet the highest standards of validity, accuracy, and veracity. Improved access to health data can assist healthcare professionals, empower patients and citizens, and help with prevention, diagnosis, management and therapy of diseases. The value of high-quality health data to the healthcare system should be considered in the transition to value-based healthcare.

04/05
14:15 - 15:05
Parallel session

The aim of the Recovery and Resilience Facility is to mitigate the economic and social impact of the coronavirus pandemic and make European economies and societies more sustainable, resilient and better prepared for the challenges and opportunities of the green and digital transitions. But how does it work? who is proposing? who is deciding? how medtech companies can access to it? come and listen to some practical national examples.

04/05
15:15 - 16:05
Parallel session

Discussions in this session will focus on the revision of the Product Liability Directive (PLD) and in particular on potential impacts of such a revision for the healthcare and medtech industry. As a way of background, the PLD adopted in 1985 introduced the regime of strict liability for defective products applicable in the EU and at the same time established a balance between consumer rights and innovation. In recent years, this balance has been challenged by certain stakeholders in particular in view of the digital technologies, especially in the field of healthcare where technology such as Artificial Intelligence (AI) holds great promise. While AI in healthcare today is subject to the Medical Device and the In-vitro Diagnostics Regulations and other existing regulatory frameworks, new AI technologies such as highly iterative and autonomous AI models may require additional/new regulatory approaches or a potential revision of existing regulatory frameworks. To respond to the rising challenges of AI technologies, the EC is considering revising PLD, including also developing new European rules for liability of AI, which may challenge the very core of the existing system and change the liability exposure for medtech manufacturers to an important extent.

04/05
15:15 - 16:05
Parallel session

#MoveYourInnovation session is dedicated to those who are contemplating innovation and want to understand how they can contribute, innovate through the advice and examples of those already onto the rollercoaster and enjoying the ups and the downs of innovation journey. #Join us!

04/05
15:15 - 16:05
Parallel session

Medical devices label contains information targeted at the user to help communicate key information for safe and effective use of the device. Increasingly, regulators mandate local country information e.g., importers, to be added to product’s label. Changes to labelling are often not only costly but they can be challenging to implement from a practical perspective. Greater efforts to promote a harmonised approach to medical devices labelling are needed. This session is going to explore various perspectives touching on what are the principles of medical devices’ labelling, what information is key to be on the medical device’s label, why are updates to product label’s difficult to implement, and what can be done to promote harmonisation of labelling requirements at the global level.

04/05
16:05 - 16:40
Networking break


04/05
16:40 - 17:30
Plenary

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.

05/05
09:00 - 09:50
Plenary

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.

05/05
10:00 - 10:50
Parallel session

The discussion in this session will focus on how codes of conduct, in particular in medtech, are evolving and how trade associations can further support companies in the compliance journey, for example with the development of specific standards to make the principles being translated into companies practices, in particular for smaller companies that do not necessarily have the necessary resources.

05/05
10:00 - 10:50
Parallel session

Medical technologies powered by artificial intelligence and machine learning can save lives, generate efficiencies, and help address the crisis in the healthcare workforce. But for it to be accepted and trusted by citizens, patients and healthcare systems alike, it needs to be appropriately regulated. This session will explore paths to regulating AI in different regions of the world.

05/05
10:00 - 10:50
Parallel session

Medical technologies have played a crucial role in the management of the COVID19 pandemic, through the provision of personal protective equipment, diagnostics tests, respiratory support equipment as well as injectables for vaccines. Companies worked around the clock to adapt to multiple production and distribution challenges, with high costs. What practices have medtech companies introduced and incorporated? A second lesson from these past two years is that pandemic preparedness is a crucial pillar of public health policies. Infectious disease threats know no borders, and dangerous pathogens that circulate are a risk everywhere. Europe must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion. To this end, the European landscape has significantly changed, with for example the introduction of a new Authority for Public health Emergency Preparedness and Response (HERA), as well as new roles for EMA and the ECDC. What did our sector learn from this crisis? Does the EU now have fully fit structures and instruments for the future? In short, is Europe ready for the next pandemic?

05/05
10:50 - 11:20
Networking break


05/05
11:20 - 12:10
Parallel session

Funding and reimbursement of digital health technologies have been a critical barrier to their adoption. Some European countries and regions have broken new ground in developing dedicated funding programmes to support digital health innovation, often starting in the domain of personal connected health or mHealth. How can fragmentation be avoided? This session convenes digital health policymakers from several European countries to discuss the potential and limits of European coordination.

05/05
11:20 - 12:10
Parallel session

China is becoming an increasingly important market for medical technologies. While the growth in many sectors of the economy is slowing, China’s medical technology market continues to grow. The medtech sector has been identified among the key priorities of China’s industrial policy for the coming years. In 2021, China published a detailed plan to foster its domestic medtech industry, promoting “dual-circulation” objectives of reducing the country’s reliance on foreign suppliers and expanding exports of domestic products. Overall, the policy environment in particular in public procurement has been challenging for foreign medtech companies to gain access to the Chinese market. Does the policy environment promoting domestic companies hamper the attractiveness of the Chinese market? What opportunities are there for European companies wanting to invest in China? What does China’s industrial policy mean for the future of the global medical technologies market? Join us for an exciting panel discussion to explore these and many other questions in depth.

05/05
11:20 - 12:10
Parallel session

In May 2022, the Medical Devices Regulation (MDR) will have been in full application for almost one year. Despite the COVID-19 pandemic, some positive progress was achieved however today the slow and piecemeal MDR implementation is still seriously holding back industry and other stakeholders to complete transition in a timely fashion. In this session, current and foreseen challenges will be analysed with a view to discuss and suggest ways on how to best solve them.

05/05
12:20 - 13:10
Parallel session

As seen from Europe, there is an abysm between medtech companies and start-ups to perform R&I together. But both types of companies can meet and actively interact together at the regional and local scale which is more favourable for practical interactions. A roundtable will put together panellists representing key stakeholders like start-ups, global companies, healthcare organisations, investors, and public administration, will introduce: successful initiatives, identify critical factors, good practices, and investments for successful R&I.

05/05
13:10 - 14:30
Networking lunch