Health technology assessments on medical devices in Europe

Rummel P, Hawlik K, Wild C
Record ID 32017000159
English
Authors' objectives: In recent years, the European collaboration on health technology assessments (HTAs), both on pharmaceutical products and (high-risk) medical devices/procedures has, due to weak market authorisation and efficacy/safety concerns, become a major issue of consideration. This research sought to explore and synthesise the critical points and challenges in the assessment of medical devices in Europe discussed in publications and to analyse a number of selected European HTA reports regarding their timing in relation to market authorisation (CE-mark), levels of evidence considered in the assessments and overlaps in topics.
Authors' recommendations: The results strongly support the assumption that the resources of HTA institutes can be used more efficiently. In contrast to pharmaceutical products entering the health care systems at almost the same time, medical devices -and subsequently their respective pre-reimbursement assessments- show a broader time span (of up to 12 years) in Europe. The knowledge gained leads to the conclusion that there is a need not only to collaborate across borders within the same year, but also to build on previous assessments on the same technologies by other (HTA) institutions, provided the same format, method, language can be used.
Details
Project Status: Completed
Year Published: 2016
URL for published report: http://eprints.hta.lbg.ac.at/1108/1/Rapid_Assessment_012.pdf
URL for additional information: http://eprints.hta.lbg.ac.at/1108/
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Austria
MeSH Terms
  • Equipment Safety
  • Europe
  • Humans
  • Technology Assessment, Biomedical
Contact
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name: tarquin.mittermayr@aihta.at
Contact Email: office@aihta.at
Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.