European Council’s Recent Revision in MedDev 2.7.1 Guidelines (Revision 4) – Quantifying its Change and its Impact

Abstract

Latest updates in guidelines of European Union for medical device clinical evaluation report (CER) is particularly in line with the shift of focus of evaluation process from “verification of safety and performance” to justification of “sufficient evidence conforming to the essential requirements” and subsequent change in the approach of clinical evaluation from a subjective justification based upon collection of information to an objective, holistic and logical clinical justification based upon clear and rational methods. Stating that the clinical evaluators need to have an experience of about 10 years in clinical research and medical writing, requiring an all-inclusive state-of-the-art for device-treated disease, and specifying clinical data sources, the guidelines have given a direction for CER to be logical and objective. The requirement to align manufacturer supplied information such as instructions for use, Clinical Investigations Report and CER is indicative of the holistic approach. These guidelines are not effective immediately, however, their merits and value addition as well as its immediate implantation is practical and operationally beneficial for the manufacturers. They have removed ambiguities about the qualifications, acceptability standards of performance and safety of the device, scope of clinical evaluation etc. and have set expectations. The guidelines are supposed to bring about two major changes in the CER trends. The first change will be in the trend of personnel. We can now expect increased engagement for medical writer with 10 years of more experience. In addition, organizations with personnel having diverse background will be in a better position to deliver the CER. Due to increased engagement in PMS, PMCF and registry activities, increased literature search and summarization requirements and frequent update of CER, need for automation will increase.