Report: EU Needs to Improve Assessment of High-Risk Medical Devices

A new report published in the journal Value in Health has found that the European Union’s (EU) assessment of high-risk medical devices is in need of improvement. The health economics and outcomes research group which performed the study analyzed data from 93 health technology assessment (HTA) reports conducted between 2010 and 2015 and found that over half of the reports demonstrated safety and efficacy based on moderate or low-quality studies.

The researchers rated the quality of the reports based on a number of factors, including the source of the evidence, the type of evidence and the level of evidence based a Cochrane Collaboration level of evidence analysis. While safety and effectiveness data on the medical devices often came from lower-quality sources such as case series or reports, in cases where high-quality studies had been performed, including systematic reviews and randomized controlled trials, many of these were found to have a high or unclear risk of bias.

These findings prompted the study team to conclude that overall evidence for the assessment of high-risk medical devices was sub-par and that regulators should require more stringent clinical trial designs from manufacturers for approval submissions.

“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,” said Britta Olberg, of the Berlin University of Technology in Germany.

Olberg and her colleagues stress that the HTA agencies which serve the EU struggle to make recommendations to healthcare bodies due to the lenient regulations surrounding medical device assessment. While studies of medical devices must adhere to good clinical practice (GCP) guidelines, they do not necessarily need to demonstrate a clinical benefit in order to be awarded a CE mark. According to the paper, this is the reason why high-risk devices are passed by regulatory bodies on the basis of poorer-quality evidence.

“The EU has revised the rules governing MDs, mainly addressing the safety of materials and increasing the requirements for obtaining CE marks,” conclude Olberg and her co-authors in the publication. “This is a very important advancement with respect to longstanding and controversial issues of the given MD regulation. Nevertheless, the new regulation still lacks requirements for mandatory high-quality evidence on the effectiveness and safety of [medical devices] for their approval.”