Background and 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.

Methods: A literature review of publications searched in Medline via PubMed supplemented by a grey literature search was conducted to identify the critical points and challenges in the assessment of medical devices in Europe. Then the ADVANCE HTA database (developed in the EU-FP7 project) was used to select a cohort group of HTA reports on high-risk medical devices conducted in 2014: Ten devices and their respective reports were selected for further investigation. Finally, a search in several databases was conducted to identify additional HTA reports on the selected technologies in previous or successive years.

Results: The issues discussed in the recent literature can be summarised in five major critical points in the assessment of medical devices: 1. Lack of robust evidence at time of assessment; 2. Methodological challenges; 3. Need for harmonisation of HTA-requirements; 4. Variable impact on decisions; 5. Timing of HTA in the life-cycle of medical devices.
The analyses of HTA reports on 10 selected high-risk medical devices revealed the amount of redundancies in European HTA production: the number of reports produced per technology ranged between 5 and 22 reports over a time-span of 10-12 years; within the same year 1-6 reports on the same technology, sometimes even within the same country (language) were produced.

Discussion and conclusion: 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.