EU HTA for Medical Devices and In Vitro Diagnostics
Evidence requirements within the European Union for innovative Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDs) are subject to fundamental change. Building on the recently introduced EU Regulations on Medical Devices (2017/745; MDR) and on In Vitro Diagnostic Medical Devices (2017/746; IVDR), the EU HTAR (2021/2282) introduces specific comparative evidence requirements for certain class IIb and class III devices.
In line with the our aim to
support the implementation of the EU HTAR to help achieve the EC’s mission of
improving patient access to life saving innovative technologies, the EAA is bringing together
multi-stakeholder experts to
identify challenges and
provide constructive input for MDs and IVDs.
Adjunct Roundtable at the EAA Spring Convention 2025:
EU HTA for Medical Devices
Approaching Performance Measurement
April 2nd, 2025 13:00 PM to 18:00 PM
in Berlin, Germany
We will discuss the definition of success and measurable success criteria for EU HTA specific to Medical Devices from each stakeholder's point of view with our expert panel including Frédérique Debroucker, Maya Matthews, Monica Otto, Valentina Strammiello, Adrian Griffin, Andrea Mantovani, Andreas Stange, Frank-Ulrich Fricke, Jürgen Wasem, Marco Marchetti, Rob Nelissen, Ruben Casado, Walter Van Dyck, Yves Verboven and many more.*
Agenda*:
Public Session
13:00 - Welcome (Jürgen Wasem, Jörg Ruof)
13:10 - Setting the Scene - Keynote Presentations - Perspectives for EU HTA in Medical Devices & Defining Success
(Maya Matthews, Marco Marchetti, Monica Otto, Valentina Strammiello, Andreas Stange, Rob Nelissen, Frédérique Debroucker)
15:30 - Panel Discussion (moderated by Ruben Casado, Frank-Ulrich Fricke)
17:00 - Hands On - Case Studies (Adrian Griffin, Andrea Mantovani, moderated by Walter Van Dyck, Yves Verboven)
18:00 - End of Roundtable
*final agenda and speakers are subject to change
EAA News & Media Posts on Medical Devices
November 19, 2024: EAA Faculty Feedback on the Draft Implementing Act on Joint Scientific Consultations for Medical Devices
With the EU HTAR introducing extensive comparative evidence requirements for some class IIb and class III devices joint scientific consultations will be crucial to allow medical device manufacturers (largely lacking extensive experience with HTA procedures so far) to prepare for their EU HTA procedures. The EAA Faculty provided feedback on the Draft Implementing Act on Joint Scientific Consultations for Medical Devices.
Events
Inaugural EAA Roundtable
on October 24th, 2024 hosted by LUISS University:
EU HTA Readiness for Medical Devices - Status of Comparative Evidence Generation for HTA
After Keynote presentations by Marco Marchetti (HTA CG Co-Chair, Director of HTA at AGENAS), Achille Iachino (Italian MoH, EMA Medical Device Coordination Group), Andreas Stange (Senior VP TÜV Süd) and Stefan Lange (CSO/CMO Dierks+Company, former Deputy Director of IQWiG) we discussed key questions for approaching EU HTA. Finally, Yves Verboven (MedTech Europe), Valeria Glorioso (Confindustria Dispositivi Medici, Milan University), Andrea Mantovani (Alira Health & LUISS University) and Gennaro Broya de Lucia (Italian Association of Medical Devices SME, PMI Sanita) discussed Health Policy implications of EU HTA for Medical Devices.
Thank you very much to all moderators, presenters, participants and contributors and to Luca Magni and LUISS University for hosting us!
Save the Date for the 2nd EAA Roundtable: EU HTA for Medical Devices
on April 2nd, 2025 in Berlin!
Watch this space for further details.