Re: Where to CE Mark a Class I medical device
Our understanding is that the CE Mark and other labeling information may be placed on packaging materials if those materials will be present when the device reaches the clinical user and if the presence of the labeling information will be obvious to that user.
That implies that the device is single use. If the device was repeated-use, some sort of proprietary storage/handling case might have to be developed for it, for the primary purpose of carrying the labeling information to the point of use.