Evidence from clinical trials on high-risk medical devices in children: a scoping review.

ABSTRACT:

Background

Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children.

Methods

Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0-21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022.

Results

From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. M

SUBMITTER: Guerlich K 

PROVIDER: S-EPMC10899114 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature