Digital medical devices (DMDs) present unique opportunities in their regulation and
reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within …

The medical technology sector is characterised by a constant influx of innovations with the
potential to revolutionise patient care. In France, there are several pathways for medical …

Several high‐risk medical devices for children have become unavailable in the European
Union (EU), since requirements and costs for device certification increased markedly due to …

ABSTRACT Introduction The new European Medical Device Regulation has raised the bar
for the clinical evaluation of medical devices to gain marketing authorization by Notified …

The reimbursement of artificial intelligence (AI)–based medical devices (MDs) is a complex
and challenging issue, depending on national market access pathways. We aim to analyze …

Objectives Identify, through a systematic review, the main domains and methods to support
health technology assessment of Medical Devices (MD) from the perspective of …

Outcome evaluation of medical devices is an increasingly addressed issue. This study
compiles publications addressing the issue of how outcomes are approached differently …

Background: Medical devices play a crucial role in the early diagnosis and treatment of
diseases. While numerous medical devices are developed globally, the focus on developing …

Outcome evaluation of medical devices is an increasingly addressed issue. This study
compiles publications addressing the issue of how outcomes are approached differently …

Vstup zdravotnických prostředků (ZP) do úhrady z veřejného zdravotního pojištění je v
České republice regulován na několika úrovních. Úhrada zdravotnických prostředků na …