The European Commission has published the guideline MDCG 2020-13 : “Clinical evaluation assessment report template (CEAR)”.
This is a clinical evaluation report used by Notified Bodies (not for Manufacturers) which explains in detail whether and how the relevant technical documentation of the medical device Manufacturer meets the needed requirements.
This document is therefore an excellent indirect tool for Manufacturers to understand whether and how the outputs of the clinical product evaluation process comply with MDR requirements.
Clinical evaluation is a challenging and fundamental process included in the MDR Medical Devices Regulation (EU) 2017/745 and, as part of the Quality Management System, must be aligned and consistent with other system processes, such as:
- risk management, throughout the lifecycle of the device;
- post-market surveillance, including any eventual security corrective action that involves the device;
- clinical post-market follow-up;
- labelling, in order to provide adequate information on the intended purpose.
What is the purpose of the new MDCG 2020-13 document?
The purpose is to provide a CEAR report template to document the clinical evaluation process. This template can be applied to Annexes IX section 4 and X section 3 of MDR (EU) 2017/745.
In addition, it can be used for the assessment of sample-based documentation for Class IIa / IIb devices in accordance with Sections 2.3 and 3.5 of Annex IX and Section 10 of Annex XI (A).
Finally, it also applies to Medical Devices for which clinical data are not considered appropriate.
CEAR Report: Instructions for use
The MDCG 2020-13 document provides information on how the Notified Body should complete the CEAR report.
The CEAR report documents the outcome and conclusions of the clinical evaluation.
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