The European Union has introduced stricter provisions for medical devices under the new
Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing …

Objectives To synthesise the available evidence of wearable cardioverter defibrillator (WCD)
therapy as an add-on measure to optimal medical therapy (OMT) or as a replacement of …

ABSTRACT In March 2020, the COVID-19 pandemic shook the European Union (EU). The
EU responded to the multifaceted challenge with an integrative leap forward. Member States …

Concerns have been raised over the quality of evidence on the performance of medical
artificial intelligence devices, including devices that are already on the market in the USA …

One of the greatest strengths of artificial intelligence (AI) and machine learning (ML)
approaches in health care is that their performance can be continually improved based on …

Abstract Background In the European Union (EU), there are over half a million medical
devices, varying from pacemakers to software. Medical devices play an important role in …

The coronavirus pandemic has systematically challenged how states govern, exposing the
weaknesses in every political system. In the first months of what became the COVID-19 …

Public health is notoriously difficult to define, and that is the case for public health in the
European Union as much as other political systems. In this article, the authors try to identify …

Background Medical device certification has undergone significant changes in recent years.
However, exploration of stakeholder experiences remains relatively limited, particularly in …

In light of rapid technological advancements, the health care sector is undergoing significant
transformation with the continuous emergence of novel digital solutions. Consequently …