The Clinical Evaluation Plan, or CEP, is a crucial starting point and guide for the clinical evaluation of your medical device. Learn more about this key document and its requirements.
Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in the EU.
For planning and documenting clinical evaluation and evidence, a well-designed and clearly written clinical evaluation plan (CEP) and clinical evaluation report (CER) are essential and required for all device classifications (Class I to III), both new and legacy devices.
These two regulatory documents required to support credible clinical evidence for the safety and performance of your device are essential for device development and approval and should comply with strict regulatory guidelines (MDR 2017/745 and MEDDEV 2.7/1 version 4).
The CEP and CER, as part of the Technical Documentation , are two critical documents reviewed by the Notified Body, an independent organization that authorizes products to be placed on the European market.
Both documents should be dated, version-controlled, and signed by the regulatory writer, evaluator s, and manufacturer.
In this blog post, you will learn more about the Clinical Evaluation Plan (CEP) , its requirements , and additional aspects that should be considered.
The Clinical Evaluation Plan or CEP (MDR Article 61 and Annex XIV, Part A; MEDDEV 2.7/1 Rev 4) is key as the start and guide of the clinical evaluation of your medical device.
This primary document describes:
In the Clinical Evaluation Plan, it is important to establish the appropriate risk class of your device (class I, IIa, IIb, or III).
The risk class determines the level of control and scrutiny required to assure the safety and performance of your device and define the conformity assessment route to follow.
