On some medical devices, the CE Marking 4-digit number displayed next to the CE Marking is the Notified Body (NB) number. If there are no CE marking 4-digits, it means that the medical device is a Class I device that does not require NB intervention (i.e., self-declared). If the device is a Class I device and there is an NB number next to the CE marking, the device has a measurement function or is sterilized.
Requirements for the 4-digit CE marking
The Medical Devices Directive is divided into articles and annexes. Article 16, Section 1 states that the European Commission is responsible for assigning NB numbers. In Article 17 ("CE Marking") it states, "[CE] shall be accompanied by the identification number of the designated body responsible for carrying out the procedures laid down in Annexes II, IV, V and VI." Annex XII defines the minimum size of the CE (i.e. 5 mm). Annex XII does not contain a requirement for the size of the NB identification number, but NB interprets the size requirement as half the height of the CE.