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October 1, 2021EFORT Open ReviewsOpen Access

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

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Why the study?

The EU Medical Device Regulation provides general principles for clinical investigations but few methodological details, creating challenges in balancing regulation, innovation, and clinical evidence.

Design

Review

Authors

AFAlan G. FraserCardiac ImagingRNRob G. H. H. NelissenLeiden UniversityPKPer Kjærsgaard‐AndersenHvidovre Hospital

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Overview

No immediate practice change; leaves open optimal methodologies for high-risk device evaluation in Europe.

Key Points

Key points are not available for this paper at this time.

Cite This Study

Fraser et al. (2021) studied this question.

synapsesocial.com/papers/6a7fcc361a67e27004152e08https://doi.org/10.1302/2058-5241.6.210081
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