Clinical Evaluation Plan (CEP)

The Clinical Evaluation Plan (CEP) is established and updated in support of a 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 CEP should identify the general safety and performance requirements that require support from relevant clinical data and should include a clinical development plan as well as a post-market clinical follow-up with an indication of milestones and a description of potential acceptance criteria. Requirements for the CEP are detailed in Annex XIV (Part A, Section 1) of the Medical Devices Regulation (2017/745).

Contact us

Fill out the form below to request more information.

 

Customer testimonial:

 

“While preparing our scientific publications with Emtex, I experienced a true sense of commitment, professionalism & excellent writing quality! A great achievement was the acceptance of our publication in Pain Physician without any questions or corrections! It was the TEAM work that made the difference.”

Associate Clinical Lead

This website uses (anonymous) analytical cookies.

More info