Manual on borderline and classification in the community regulatory framework for medical devices
ID 6024 | Update 08.07.2021 - Version 1.22 (May 2019)
Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded [...]






























