Medical Devices and the Evolving European Union Policy Landscape

Published Nov 12, 2018
Barcelona, Spain—12 November 2018—ISPOR, the professional society for health economics and outcomes research, held a session this afternoon at ISPOR Europe 2018, “The Evolving European Union Policy Landscape: Are We On the Right Path to Improve Clinical and Economic Outcomes Research of Medical Devices?” [IP11]. In this session, speakers debated how to best improve clinical and nonclinical evidence generation for medical devices at each stage of product lifecycle in the European Union (EU). Speakers for this session included:
  • Moderator: Rosanna Tarricone, MSc, PhD, SDA Bocconi School of Management, Milan, Italy
  • Carlo Federici, MSc, SDA Bocconi School of Management, Milan, Italy
  • Flora Giorgio, PhD, European Commission, Brussels, Belgium
  • Jean Luc Lemercier, PharmD, Edwards Lifesciences, Irvine, CA, USA
Historically, marketing approval for medical devices in the EU has focused on the proof of safety as a minimum requirement where approval could be granted based on preclinical evidence alone. New EU regulation on medical devices, however, sets stricter evidential requirements for market access. Additionally, the proposed regulation on European cooperation on health technology assessment (HTA) may impact coverage and reimbursement decisions by national HTA bodies. The proposed regulation promotes closer collaboration among industry, regulators, and payers in the early stages of product development. Dr Giorgio outlined the new EU regulation on medical devices and the proposed EU regulation on HTA cooperation noting that this could ultimately accelerate patient access to potentially beneficial medical devices. Mr Federici offered an overview of the methods that can be used for early assessment of medical devices. Dr Lemercier discussed the challenges that industry faces with preclinical and clinical outcomes research in light of the changing EU regulatory framework. ISPOR is recognized globally as the leading professional society in HEOR and its role in improving healthcare decisions. ISPOR Europe 2018 is the leading HEOR conference in Europe and draws more than 5000 healthcare stakeholders, including researchers and academicians, assessors and regulators, payers and policy makers, the life sciences industry, and patient engagement organizations. Additional information on ISPOR Europe 2018 can be found here. Released presentations from the conference can be found here. Interested parties can follow news and developments from the conference on social media using the hashtag #ISPORBarcelona.


  ABOUT ISPOR ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field. Web: | LinkedIn: | Twitter: (@ISPORorg) | YouTube: | Facebook: | Instagram:

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