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. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. Conclusion Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children. Impact In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.

European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children

“…To assist the experts in recommendations development, EAP charged the Child Health Foundation at LMU (Stiftung Kindergesundheit) to perform a scoping review on evidence from clinical trials investigating high‐risk medical devices in children (Guerlich et al, under review) 8 . Key review findings shared with the workshop participants in advance, were based on the evaluation of a sample of 99 included clinical trials.…”

Paediatrics and Child Health Need a United, Credible and Strong Pan-European Voice

“…devices for interventional paediatric cardiology, dialysis equipment for young children) are becoming unavailable. EAP has led the Task on paediatric devices in the EU Horizon Framework project “ Coordinating Research and Evidence for Medical Devices ”, performed a systematic review to evaluate the availability of clinical evidence, 1 and developed und published joint recommendations with 24 organisations on the topic 2 and disseminated this widely, for example at the International Medical Device Regulators Forum and political decision makers at European and national levels We also wrote an open letter demanding rapid changes with 27 associations and received a positive response letter by the President of the European Commission, Dr. Ursula von der Leyen. Consequently, constructive collaboration has evolved with the European Commissions’s Medical Device Task Force where EAP is now participating, aiming to develop solutions.…”