Where the initiative stands after 18 months
Work Package 1 aims at understanding the methods that have been used to generate clinical evidence for high-risk medical devices.
Comparison between the all-cause revision rates in the published literature and in the most recent registry reports is being undertaken so as to describe whether safety concerns for a specific device expressed in published studies are concordant to its real-world safety reported by registries
As regards methodologies used in published prospective clinical studies of high-risk cardiovascular medical devices the identified challenges reported by partners covered non-RCT papers which were classified as “high-risk of bias” due to poor reporting and unclear design.
Work Package 2 aims at strengthening the clinical evidence for high-risk medical devices by exploring new methods for generating data about their performance.
In the field of Artificial intelligence, a guidance for the evaluation of AI and stand-alone software in medical devices is being developed. Publication of an article is underway.
CORE-MD partners are also identifying and describing methodologies and approaches used to evaluate high-risk medical devices in children and address ethical aspects of clinical evaluation in paediatric patients.
The main objective of Work Package 3 is to extract maximal value from medical device registries and real-world evidence.
According to partners, registries were important data sources to help manufacturers in fulfilling the MDR requirements, despite their large heterogeneity in coverage, completeness, and methods to ensure validity of data.
A mashup tool collecting clinical reports of devices has been elaborated in the framework of CORE-MD. The tool applied to few countries provides for an effective and useful approach both for notified bodies and regulators.
Work Package 4 and Work Package 5 will focus respectively on engagement with stakeholders, and project management.
The preliminary results from the interviews showed that the focus should be on academic curriculum for all stakeholder groups rather than a single Master on Regulatory Affairs with specific attention on methodology of clinical evaluation.