While there are several new requirements related to CER content contained in MEDDEV 2.7/1 rev 4 and the MDR, one of the more perplexing issues concerns the issue of “equivalency.”
Companies selling devices compliant with 93/42/EEC have long used existing scientific literature and equivalent device statements in their CERs. The purpose of doing so is to avoid having to conduct redundant pre- or postmarket clinical studies that prove safety and performance. However, the very definition of “equivalent” was not specified in the Medical Devices Directive (93/42/EEC), leaving much room for interpretation.… » Read more
As many veteran QA/RA professionals are painfully aware, the days of a 10-page Clinical Evaluation Report (CER) are a blissful memory of a bygone era. Today’s medical device CERs are now substantial in content, dynamic through the entire life cycle of a product, and essential for maintaining certification in the EU and other markets.
The CER is intertwined with the larger assortment of technical documentation that includes your risk management file and postmarket surveillance data. Countries such as China and Australia are increasingly scrutinizing CERs and expecting them to be far more integrated into your overall regulatory processes.… » Read more