Clinical Evaluation Reports Under the New EU MDR

by | Dec 18, 2019 | EU MDR, Medical Devices

The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017, marking the beginning of the transition period for any medical device manufacturer selling devices in Europe.1 This new regulation replaces the Medical Devices Directive and the Active Implantable Medical Devices Directive and includes changes to several critical requirements. Medical device manufacturers will notice that there are updated
requirements for technical files, and specifically for clinical evaluation reports. In this paper, we will cover what a clinical evaluation report is and how the requirements under the new regulation differ from the previous directive.

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Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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