Services
The Clinical Evaluation Report (CER) documents the results of the clinical evaluation of a medical device, which is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to the device. The CER supports the assessment of conformity of the device with the general safety and performance requirements when used as intended by the manufacturer and is part of the technical documentation of the device. The CER is described in Annex XIV (Part A, Section 4) of the Medical Devices Regulation (2017/745) and guidance is provided in MEDDEV 2.7/1 revision 4. The CER must be aligned with the Clinical Evaluation Plan (CEP).
Emtex Life Science medical writers can manage and coordinate the document development process (eg, compile contributions, circulate for review, implement comments) and can help to generate a clear, well structured, and coherent document.
FAQ: Clinical Evaluation Report
What is a Clinical Evaluation Report (CER)?
A CER documents the results of the clinical evaluation of a medical device. The CER summarizes the systematic and planned process used to generate, collect, analyze, and assess clinical data related to the device.
What is the purpose of a CER in the development of a medical device?
The CER supports the assessment of conformity of the device with general safety and performance requirements. It demonstrates that the device performs as intended by the manufacturer and forms part of the technical documentation required for regulatory compliance.
Which regulations define the requirements for a CER?
The requirements for the CER are described in Annex XIV (Part A, Section 4) of the Medical Devices Regulation (2017/745). Additional guidance is provided in MEDDEV 2.7/1 revision 4.
How can Emtex Life Science support the preparation of a CER?
Emtex Life Science can support the CER process by coordinating contributions from relevant functions, organizing review cycles, implementing comments, and ensuring that the CER is clearly structured and aligned with the Clinical Evaluation Plan (CEP) and with regulatory expectations.
Why is professional medical writing support valuable for a CER?
Professional medical writing support is valuable because a CER must be coherent, well‑structured, and consistent with the CEP and regulatory requirements. A medical writer ensures clarity, accuracy, and logical flow, improving the quality and reliability of the CER within the technical documentation.