An Integrative Systematic Review of Patient Reported Outcome Measures (PROMs) Used to Evaluate Orthopedic, Cardiovascular and Diabetes High Risk Implantable Medical Devices.

Clinical evidence of high-risk medical devices for diabetes management: A systematic review and meta-analysis

Post-approval evidence development schemes established by regulatory authorities for high-risk medical devices .

Database of studies of high-risk medical devices. Deliverable 1.1

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

Tool to retrieve public information on medical devices

Orphan Medical Devices and Pediatric Cardiology – What Interventionists in Europe Need to Know, and What Needs to be Done

Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD Consortium

Study Design Recommendations in ISO Standards for High-risk Medical Devices, a Systematic Review of the Horizon2020 CORE-MD Project

Clinical evidence for high-risk medical devices in cardiology: a protocol for a systematic review and meta-epidemiological investigation.

Implementation of the new EU IVD Regulation – urgent initiatives are needed to avert impending crisis.

Artificial intelligence in cardiology: the debate continues

Development of an IT tool for assisting Medical Devices Post-Market Surveillance: application to the Italian scenario

The CORE-MD initiative and its potential impact on orthopaedic practice

Orthopedic and cardiovascular medical device registries in Europe: a systematic review

Clinical investigations to evaluate high-risk orthopaedic devices: systematic review and meta-analysis

Responsibilities and roles of Notified Bodies

New Medical Device Regulations Take Effect in Europe

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices

Regulation (EU) 2017/745 on Medical Devices

The need for transparency of clinical evidence for medical devices in Europe

Clinical Evaluation

Challenges with coverage with evidence development schemes for medical devices: a systematic review

Implementing the new European Regulations on medical devices—clinical responsibilities for evidence-based practice

CORE-MD project handbook