Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Rosanna Tarricone, Aleksandra Torbica, Francesca Ferré, Mike Drummond

Research output: Contribution to journalArticlepeer-review


Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

Original languageEnglish
Pages (from-to)707-718
Number of pages12
JournalExpert Review of Pharmacoeconomics & Outcomes Research
Issue number5
Early online date8 Sept 2014
Publication statusPublished - Oct 2014

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