Volume 29, Issue 4 - Writing for Patients
Medical Devices
Authors: Kelly Goodwin Burri, Laura C. Collada Ali, Katharina Friedrich
Abstract
The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome. The MDR enforces stricter rules on the clinical evaluation process with a focus on safety and performance of medical devices and introduced several new document requirements
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