This session will look into opportunities and challenges with application procedures and performing a combined clinical trial in Europe, that involves a medicinal product and an in vitro diagnostic (IVD), or companion diagnostic (CDx) and/or a medical device (MD) component. The clinical trial application for the medicinal product is submitted under the Clinical Trial Regulation (CTR) via CTIS, while the device/diagnostic follow different national procedures. An update on the COMBINE project will be included. 

Multiple stakeholders (i.e. Pharmaceutical companies, device manufacturers, EMA, NCAs, Notified Bodies and academic institutions) are involved in the development of innovative drugs (using devices). The device regulation (MDR and IVDR) has introduced major changes and has been suggested as a contributing factor to the decrease in the number of clinical trials in Europe. 

The European Commission and EU Member States have launched the COMBINE initiative to propose solutions for combined trials (drug using a device in a clinical trial), specifically looking at the interplay of IVDR, MDR and CTR, also identified as one of “most important issues” by stakeholders ACT-EU workplan ‘25-’26. The panel discussion will explore whether the proposed solutions stemming from this highly welcomed initiative are already demonstrating benefits. It will also offer concrete strategies to ensure the European clinical trial ecosystem is well-suited to promote the conduct of clinical trials in Europe. 

Session Leaders:

 

Margareth Jorvid CEO, Regulatory Affairs & Quality Assurance  Methra Uppsala AB, Sweden

Claudia Popp Head EU Regulatory Science & EMA Liaison Roche, Switzerland

Speakers will include:

 

Olga Tkachenko Policy Officer  European Commission, Belgium

This session will explore the changes in Artificial Intelligence Legislation and Policy in different geographical regions, and their impact on medical devices, including discussions on the EU AI Act. 


Session Leaders:

 

Célia F. Cruz MTOPRA Managing Partner & Chief Regulatory Affairs Officer  Complear Health, Portugal

Speakers will include:

 

Hannah Bowden AI Airlock Programme Delivery Lead  MHRA, United Kingdom	Steffen Luckner Federal Ministry of Health (Bundesgesundheitsministerium [BMG]), Germany

 

This session will explore the latest and upcoming changes in the legislation impacting the medical device and IVD regulatory sphere in some key markets.  

Session Leader:

 

Ashleigh Batchen MTOPRA Regulatory Strategy Principal (UK) TÜV SÜD, United Kingdom

 

This session will explore the latest updates from the International Medical Device Regulators Forum (IMDRF) with regards to implementation of IMDRF principles, data exchange and how this all supports international reliance mechanisms. An overview of the latest developments with EUDAMED, SwissdaMed and FDA Medical Device Databases will be shared. 

Session Leader:

Natasha Bankowski MTOPRA Principal Consultant Medical Technology DLRC, United Kingdom

Speakers will include:

Steve Lee Director, Diagnostics and Digital Regulation  ABHI, United Kingdom	Richard Houlihan CEO Eirmed Ltd, Portugal

 

 

This session will provide the latest updates on the European Medical Device Regulation (MDR), focusing on its implementation progress, ongoing challenges, evolving regulatory requirements and the review processes being conducted. 

Session Leader:

Ashleigh Batchen MTOPRA Regulatory Strategy Principal (UK) TÜV SÜD, United Kingdom

Speakers will include:

Olga Tkachenko Policy Officer  European Commission, Belgium	Christina Ziegenberg Deputy Managing Director BVMed, Germany

This session will provide an exploration of the conformity assessment process for various types of in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Regulation (IVDR). As manufacturers navigate increasingly stringent requirements, understanding the specific challenges and opportunities associated with different device categories is essential for successful compliance. 

Session Leader:

Stuart Angell Managing Director and Co-Founder  IVDeology Ltd, United Kingdom

Speakers will include:

Alex Laan Head of the IVD Notified Body BSI, United Kingdom

 

This session will explore the rapidly evolving landscape of digital health, focusing on Germany’s Digital Health Applications (DiGA) framework and the UK’s Digital Mental Health Technology Project. As digital health solutions gain prominence in healthcare systems, understanding regulatory pathways and integration strategies is essential for promoting innovation and patient access. 

Session Leader:

Célia F. Cruz MTOPRA Managing Partner & Chief Regulatory Affairs Officer  Complear Health, Portugal

Speakers will include:

Francesca Edelmann Manager, Digital Mental Health  MHRA, United Kingdom	Henrik Emmert Member of the Board Spitzenverband Digitale Gesundheitsversorgung, Germany	Wolfgang Lauer Head of the Medical Devices Division Federal Institute for Drugs and Medical Devices (BfArM), Germany

This session will provide attendees with the latest updates on the European In-Vitro Diagnostic Regulation (IVDR), offering valuable insights into its implementation, challenges, and evolving regulatory landscape and the review processes being conducted. 

Session Leader:

Ashleigh Batchen MTOPRA Regulatory Strategy Principal (UK) TÜV SÜD, United Kingdom

Speakers will include:

Steffen Luckner Federal Ministry of Health (Bundesgesundheitsministerium [BMG]), Germany	Olga Tkachenko Policy Officer  European Commission, Belgium

 

Since the implementation of the MDR and IVDR, a procedure for the assessment of a single application for studies in the EU to be coordinated between Member States was presented. The idea behind this procedure is to reduce administrative burden and allow for resource-sharing in order to ensure consistency regarding the assessment of health and safety-related aspects of investigational devices/device for performance study and of the scientific design of the clinical investigations/performance studies. Soon, the voluntary character of the coordinated assessment will transition into a mandatory character, as we come close to the end of the 7 years mark after adoption of the MDR and IVDR.  

In this session, experts from the competent authorities dive deeper into the current status of implementation of this procedure, and the impact for studies reaching outside of the EU borders. 

Session Leaders:

Maaike Labots Manager Medical Writing Avania, The Netherlands	Alwin van den Broek Director Clinical Operations & Data Protection Officer BeVinced, The Netherlands

Speakers will include:

Daniel Hill Deputy Head of Clinical Investigations MHRA, United Kingdom	Ulf Schriever Federal Institute for Drugs and Medical Devices (BfArM), Germany

This session will provide valuable insights into the regulatory framework surrounding Class D devices, focusing on the role of the European Union Reference Laboratories (EURL) network. Experts will discuss the ongoing harmonization process, collaboration with notified bodies, and the critical aspects of batch testing and performance evaluation. 

Session Leader:

Ashleigh Batchen MTOPRA Regulatory Strategy Principal (UK) TÜV SÜD, United Kingdom

Speakers will include:

Alex Laan Head of the IVD Notified Body BSI, United Kingdom	Karin Metzner Director EURL-IVD Paul-Ehrlich-Institut, Germany	Olga Tkachenko Policy Officer  European Commission, Belgium

 

Medical device post-market surveillance presents unique challenges due to the greater diversity and complexity of medical devices, the iterative nature of medical product development, the learning curve associated with technology adoption, and a relatively short product life cycle. There is a lack of alignment in terminology globally and there are mulitple/complex data sources. This session will explore real-world case studies that illustrate how to create and implement robust post-market clinical follow-up (PMCF) activities and how to successfully integrate these findings into key regulatory documents – such as PMSRs, PSURs and CERs. The Notified Body and competent authority will share their opinions regarding challenges encountered in the post-market phase and the best way to overcome these challenges. 

Session Leader:

Natasha Bankowski MTOPRA Principal Consultant Medical Technology DLRC, United Kingdom

Speakers will include:

Nikhil Aravind Khadabadi Chief Medical Officer Orthopaedic and Spine devices Eclevar Medtech, United Kingdom	Ekkehard Stößlein Federal Institute for Drugs and Medical Devices (BfArM), Germany

This session will provide discussion on evidence generation for IVDs, learnings on good practice, and the challenges faced. 

Session Leader:

Stuart Angell Managing Director and Co-Founder  IVDeology Ltd, United Kingdom