High-Risk Medical Devices Granted European Licensure Based on Low-Quality Evidence

Value in Health Report Strongly Recommends Enforcing a Requirement of High-Quality Studies for Demonstrating Clinical Efficacy and Safety


Lawrenceville, NJ—January 2, 2018—Value in Health, the official journal of ISPOR (the professional society for health economics and outcomes research), announced today the publication of a research report concluding that the quality of scientific evidence used in the health technology assessment of high-risk medical devices in countries in the European Union is low and needs improvement. The report was published in the December 2017 issue.

The article, Scientific Evidence in Health Technology Assessment Reports: An In-Depth Analysis of European Assessments on High-Risk Medical Devices, describes the authors’ systematic examination of the scientific evidence on clinical effectiveness and safety used in 93 relevant health technology assessment (HTA) reports of high-risk medical devices in Europe. In more than half the identified studies considered in the reports, clinical evidence for demonstration of effectiveness and safety was of moderate or low quality. Even when systematic reviews and randomized controlled trials were available for assessment, most studies showed an unclear or high risk of bias.

These findings are of great concern because they reflect a tremendous hurdle faced by European HTA agencies in their task of making adequate recommendations to health care decision makers. Although medical device investigations must adhere to principles of good clinical practice, there is no legal requirement for valid demonstration of the clinical benefit of a device in order for it to be in compliance with applicable directives. As a consequence, many high-risk devices are granted licensure based on low-quality evidence.

“This evidence gap is a well-known problem and stands in stark contrast to the very strict requirements in the approval process for pharmaceuticals,” said corresponding author Dr. Britta Olberg, MScPH, of the Berlin University of Technology, Germany. “Yet, to our knowledge, this is the first attempt to document the issue on a wide scale. Our results show that additional changes are necessary, specifically with regard to the marketing authorization process of medical devices, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources. We strongly recommend enforcing a requirement of high-quality studies for demonstrating the clinical efficacy and safety of high-risk medical devices.”



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: www.ispor.org | LinkedIn: http://bit.ly/ISPOR-LIn | Twitter: http://bit.ly/ISPOR-T (@ISPORorg) | YouTube: http://bit.ly/ISPOR-YT | Facebook: http://bit.ly/ISPOR-FB


Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help health care leaders make evidence-based decisions. The journal’s 2016 impact factor score is 4.235. Value in Health is ranked 3rd out of 77 journals in health policy and services, 7th out of 347 journals in economics, and 9th out of 90 journals in health care sciences and services. Value in Health publishes 10 issues a year and circulates to more than 10,000 readers around the world.
Web: www.ispor.org/valueinhealth_index.asp | Twitter: http://bit.ly/ISPORjournals-T (@ISPORjournals)

Posted in Announcements, ISPOR Journals, ISPOR News & Press, Value in Health Tagged with: , ,