Even as this white paper is written, there are many moving parts in the “chess game” of the medical device industry’s guiding
regulations and standards.4
For example the MDD and the CE mark, the main standards for medical devices in the European
Union, are currently in the process of being fully replaced by the new European Medical Device Regulation (MDR) which is
already official law.5 MDD compliance and CE mark will still be recognized for several years but will become extinct soon enough
as certifications are a regulatory oriented process. For the purposes of this paper however it is important to recognize that ISO
13485 will remain a critical aid in supporting compliance with the current MDD and other countries who deploy prescriptive
systems for quality.