Cumulative risk of revision after primary total hip arthroplasty in registries: Systematic review and meta-analysis of selected hip stems and cups

CORE-MD Booklet – Final Conference

CORE-MD Podcast – Alan Fraser & Per Kjaersgaard-Andersen – How do surgeons choose which Medical Device to implant?

Randomized controlled trials remain underutilized

CORE-MD Podcast – Alan Fraser & Berthold Koletzko – Providing Medical Devices for children

CORE-MD Podcast – Alan Fraser & Perla Marang-van de Mheen – Real-world evidence on the performance of High-Risk Medical Devices

CORE-MD Podcast – Alan Fraser & Richard Holborow – Understanding how EU Notified Bodies work

Focus on interventional cardiology: the need for quality and transparency of evidence for implantable cardiovascular medical devices

Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go

, Development of an AI-based IT tool to support medical device nomenclature standardization for postmarket surveillance by automated mapping from GMDN to EMDN standards

Development of a Framework Dealing with Partial Data Unavailability and Unstructuredness to Support Post-Market Surveillance

European cardiovascular registries as reliable data sources to assess implants safety and performances across the implant lifecycle.

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature

AI medical devices – review of definitions and expert recommendation

Evidence from clinical trials on high-risk medical devices in children

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

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management:

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

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

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

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

Perceived training needs of regulators, notified bodies and clinicians for a (successful) implementation of the Medical Device Regulation: survey results

Achieving consensus on items needed to assess the quality and analysis of registry data for the regulatory evaluation of medical device performances during post-market surveillance: which items are the minimum requirements?

Tool to retrieve public information on medical devices

Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ PostMarket Surveillance

Clinical evidence for high-risk medical devices in children: A protocol for a scoping review

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

Study design recommendations in guidance documents for high-risk medical devices. A systematic review

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

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

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

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