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Clinical Evaluation Plan


To navigate EU MDR smoothly, the first and primary document to be prepared is a Clinical Evaluation Plan (CEP). A CEP is a tool that helps in


Chapter VI, Article 61 of the EU MDR details the relevant aspects to be considered for the critical evaluation of the clinical data that support the general safety and performance requirements (GSPRs).

Clause no. 1 has indicated the planning, conducting, and documenting of the clinical evaluation.  Annex XIV, Part A explains the details explicitly to be covered in the CEP.


The Clinical Evaluations Plan also includes

Let us now understand about EU MDR Clinical Evaluation Plan Requirements & Contents:



Since CEP helps in resource planning and helps improve operations, a manufacturer must seek professional help to get optimum solutions.


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