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.
THANK YOU for joining the EAA Spring Convention's
Adjunct Roundtable: EU HTA for Medical Devices
'Approaching Performance Measurement'
HTA for Medical Devices needs to consider many different factors and variables many of which differ substantially from those for Medicinal Products. EU HTA poses opportunities but also a range of challenges for the MD that are in scope for JCA.
Thanks so much to our expert panel who provided excellent and thought-provoking input, updates, lots of food for though, and fuelled our discussions on the approach to success measurement in this field.
Presentations and Recordings are now available below.
Events
EAA Roundtable: EU HTA for Medical Devices
'Approaching Performance Measurement'
on April 2nd, 2025, in Berlin.
Abstracts:
Monica Hildegard Otto & Rosanna Tarricone (SDA Bocconi School of Management, Centre for Research on Health and Social Care Management (CERGAS)): Overcoming the Silos - How Cross-Fertilisation of the MDR and HTAR could Optimise Medical Device Access Across Europe
Walter Van Dyck & Yves Verboven (Vlerick Business School, Healthcare Management Centre): Addressing uncertainty of the added value of the EU HTA Regulation on HTA for highly innovative novel medical devices
Videos & Presentations:
Welcome by Jürgen Wasem
(University of Duisburg-Essen)
and Jörg Ruof
(EAA Secretariat)
Marco Marchetti
(Co-Chair at HTA Coordination Group)
Panel Discussion -
Key Performance Indicators for EU HTA
(M. Otto, V. Strammiello, A. Stange, R. Nelissen, F. Debroucker)
Hands-On Case Studies -
Andrea Mantovani
(Partner at Alira Health & Lecturer at LUISS Business School)
Final Discussion
moderated by Walter Van Dyck & Yves Verboven (both Vlerick Business School)
Inaugural EAA Roundtable
on October 24th, 2024 hosted by LUISS Business School:
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 Business School for hosting us!
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.