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Main Title: Health technology assessment of medical devices in europe: processes, practices, and methods
Author(s): Fuchs, Sabine
Olberg, Britta
Panteli, Dimitra
Busse, Reinhard
Type: Article
Language Code: en
Abstract: Objectives: To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. Methods: A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution. Results: Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit. Conclusions: Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.
Issue Date: 2016
Date Available: 27-Oct-2017
DDC Class: 610 Medizin und Gesundheit
Subject(s): health technology assessment
medical devices
health policy
Sponsor/Funder: EC/FP7/305983/EU/Advancing and strengthening the methodological tools and practices relating to the application and implementation of Health Technology Assessment (HTA)/ADVANCE_HTA
Journal Title: International journal of technology assessment in health care
Publisher: Cambridge University Press
Publisher Place: Cambridge
Volume: 32
Issue: 4
Publisher DOI: 10.1017/s0266462316000349
Page Start: 246
Page End: 255
EISSN: 1471-6348
ISSN: 0266-4623
Notes: Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
Appears in Collections:FG Management im Gesundheitswesen » Publications

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