How “Equivalent” Does a Medical Device Need to Be Under the New EU MDR and MEDDEV 2.7/1 rev 4?

Involved in updating medical device Clinical Evaluation Reports? Check out these tips from the pros. 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 that complied with the old Medical Devices Directive 93/42/EEC long used existing scientific literature and equivalent device statements in their CERs. The purpose of doing so was to avoid having to conduct […]

Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4

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 […]