German industry clarifies CE mark stance
This article was originally published in Clinica
Six German medical associations including the medical device industry association, BVMed, and the diagnostics industry association, VDGH, have published a pamphlet aimed at providing clarity about the role of the CE mark on medical devices. Aimed at distributors, sales people, manufacturers, users and patients, it states that the CE mark indicates that the manufacturer has conformed to legal requirements in the production of the medical device. It also provides information on relevant monitoring authorities and categorically states that no additional quality assurance marks are needed on medical devices as they cannot contribute to increased safety, and would only lead to confusion.