As manufacturer or developer of a medical device, you may already have experienced that providing enough clinical evidence that your products works as intended is not as easy as hoped. Through all those regulations it may sometimes seem impossible to develop structural clinical evaluations. You may experience confusion, especially now that the new regulation (Medical Device Regulation [MDR] 2017/745) is coming up in 2020. This blog may aid in understanding and provide guidance on the first step of providing clinical evidence: writing a Clinical Evaluation Plan (CEP).
The requirement for planning your clinical evaluation is not new. MEDDEV 2.7/1 revision 4 already stated that before a clinical evaluation is undertaken, the manufacturer should define its scope. This scope serves as a basis for further steps. Under the MDR, however, it is recommended to provide a separate CEP in addition to the clinical evaluation itself. As the strategy of the clinical evaluation is determined in the CEP, this will guide you through the whole evaluation process. Predetermining the steps that need to be taken, a more robust and trustworthy clinical evaluation can be performed. Moreover, the CEP can be updated with new information and/or identify gaps in the information from previous clinical evaluations. The CEP should address the gaps and associated steps that need to be taken to provide answers to the unanswered questions. This will increase the quality of your clinical evaluations.
The purpose of a CEP is to define the scope and document the approach of a clinical evaluation. The CEP should provide an identification of the general safety and performance requirements that require support from clinical data, which shall later be addressed in the clinical evaluation. The CEP should provide detailed information about the device(s) under evaluation, a specification of the intended purpose, intended target groups, indications, contraindications, and a detailed description of the intended clinical benefits and clinical outcome parameters. Next, what is your plan regarding identification of pertinent data, data appraisal, and the analysis of the clinical data? There are several sources of information you can use, including data held by the manufacturer and data from the literature. Plan how this information need to be identified, appraised, and analyzed. Finally, don’t forget how to address safety issues identified for the device under evaluation.
Hopefully this blog helps you in understanding the need for a CEP, and gives you the guidance for how to design such a plan. If you are eager to know more, or prefer additional guidance, do not hesitate to contact us, as we can help you through all the requirements necessary to increase the quality of your CEP.