ESC Announces First Meeting of CORE-MD to Assess High-Risk Medical Devices in EU

April 16, 2021—The European Society of Cardiology (ESC) announced that the methods for evaluating high-risk medical devices will be reviewed in the European Union- (EU-) funded CORE-MD project, which is holding its initial meeting on April 16.

According to ESC, the project launch comes as new EU medical device regulations come into force on May 26, 2021. The regulations increase the requirements for clinical evidence on high-risk medical devices. However, there are no specific EU recommendations on the design and conduct of trials for high-risk devices. In addition, medical device developers have expressed concerns that the new rules may inhibit innovation and delay market access, noted the society.

ESC noted that more than 50% of high-risk implantable medical devices in Europe are used in cardiology (eg, heart valves) and orthopedics (eg, hip replacements). CORE-MD will focus primarily on these areas.

According to ESC, the 3-year CORE-MD project will do the following:

• Begin with a systematic review of methodologies used in clinical trials to evaluate high-risk medical devices, including statistical methods and the utility of patient-reported outcomes for regulatory decisions.
• Propose how to generate evidence using innovative methodologies like randomized registry trials and how to assess artificial intelligence algorithms that are designated as medical devices.
• Examine how to evaluate medical devices used in children.
• Provide advice on ways to extract maximum value from real-world evidence including medical device registries and clinical practice.

Recommendations from the CORE–MD consortium will be submitted to the Working Group on Clinical Investigation and Evaluation of the European Commission, so that they can be considered as the basis for developing EU guidance documents or common specifications.

CORE-MD Scientific Coordinator Professor Alan Fraser, MD, of the ESC commented in the society’s announcement, “High-risk medical devices should be approved based on scientific and clinical evidence. Experts need to advise how regulators can achieve an appropriate balance between innovation, safety, efficacy and cost-effectiveness. We look forward to doing that through our unique collaboration of medical associations, EU regulators, national public health institutes, notified bodies, academic institutions, patient groups, and health technology assessment agencies, with participation of manufacturers’ trade associations.”

Professor Rob Nelissen, MD, of EFORT, the European Federation of National Associations of Orthopedics and Traumatology, added, “Ultimately, the overall impact of CORE-MD will be to improve the benefit/risk ratio of new implantable medical devices and other high-risk devices for patients. We aim to see wider adoption of optimal methodologies for clinical investigations by both researchers and manufacturers, fewer approvals with limited evidence, and greater transparency of standards.”