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Writing a Clinical Evaluation Plan for Medical Devices

Level:
Foundation
Area:
Medical Devices
Code:
MDF8
Duration:
03:00:00
Workshop profile:
This workshop is intended for medical writers with little or no experience in regulatory writing under the Medical Devices Regulation 2017/745 (EU MDR) who would like to learn how to prepare a compliant Clinical Evaluation Plan. There is no prerequisite to attend this workshop, but basic knowledge of clinical research methodology and medical device terminologies will be useful.
Objective:
The Clinical Evaluation Plan (CEP) is a key document that provides the foundation on which the clinical evaluation of a medical device is based. The objective of this workshop is to introduce participants to the regulatory requirements for this document and provide them with an understanding of how a well-written CEP can streamline the clinical evaluation process.
Content:
The workshop will provide a detailed overview of the contents of the CEP required under EU MDR. Specific topics covered include determining the clinical evaluation strategy best suited to your medical device, special considerations for legacy devices and new development, identifying appropriate safety and performance measures, identifying suitable equivalent or benchmark devices, the Clinical Development Plan, and an initial assessment of PMCF needs. The workshop will include group exercises and examples for low, medium, and high-risk class devices.