Under the leadership of the Department of Cardiology, Bern University Hospital, CORE-MD partners work on a protocol for a systematic review to critically evaluate the methodologies applied in clinical investigations to evaluate high-risk medical devices in cardiovascular medicine.

Experts should advise on the evaluation process of high-risk medical devices in clinical investigations. As a matter of fact, the aim is to provide information that enable regulators to make informed decisions in terms of innovation, safety, performance and cost-effectiveness. Implementation of the new Medical Device Regulation challenges the medical community to engage with regulators, notified bodies and industry. The objective is to develop transparent, rigorous and proportionate methods to evaluate the clinical safety and efficacy of devices and monitor their performance.

The CORE–MD consortium will address this challenge in a unique collaboration between medical
associations, EU regulators, national public health institutes, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, with participation of manufacturers’ trade associations.

The study protocol has been developed based on previously established guidelines for reporting and conducting qualitative research by using rigorous and systematic approaches. The final version of the systematic review will be prepared based on the updated PRISMA 2020 statement.

cover page of the protocol

Read the protocol in details