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CE marking 4 digit number for medical devices

fourdigitquestion CE marking 4 digit number for medical devicesThis article explains the purpose and use of a CE marking 4 digit number for medical devices, minimum size requirements and other considerations. 

CE marking 4 digit number

The CE marking 4 digit number that is displayed next to the CE mark on some medical devices is the Notified Body (NB) number. If there is no CE marking 4 digit number, this means that the medical device is a Class I device that does not require NB involvement (i.e., self-declaration). If the device is a Class I device, and there is a NB number next to the CE mark, then the device either has a measuring function or is sterile.

Requirements for CE marking 4 digit number

The Medical Device Directive is divided into Articles and Annexes. Section 1 of Article 16 indicates that the European Commission is responsible for assignment of NB numbers. In Article 17, ¨CE Marking,¨ it states: ¨[The CE] shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.¨ Annex XII defines the minimum size (i.e., 5 mm) of the CE. The requirements for the size of the NB identification number is not included in Annex XII, but NBs interpret the requirements for size as half the height of the ¨CE.¨

Companies are responsible for reproducing the CE Mark on their labeling and the product–including the 4-digit number. However, if the space available on the product is too small to allow a 5 mm ¨CE,¨ then the company is not required to reproduce it on the product. Instead, it is sufficient to reproduce the CE Mark on product labeling and the Instructions For Use (IFU). One source of the artwork for the ¨C¨ and ¨E¨ is the Europa website.

If a NB number is required, usually there are a couple of different orientations that are allowed by the NB. Most NBs specify that the NB number shall be to the right or beneath the “C” and “E”. However, most NBs have specific instructions available for reproduction of the CE Mark and the proper orientation of their NB number. Often, the NB will also provide artwork for downloading that includes the NB number in one or more orientation.

Product Failure Investigations

Identification of the NB may not seem important, however, the NB number can help caregivers to identify the NB that approved CE Marking of a product when there is an investigation of product failures with an unknown manufacturer. In that case, the NB will then share this information with the appropriate manufacturer in order to facilitate an investigation. The NB number is also used to differentiate when the oversight by one NB stops, and a new one begins, after transferring from one NB to another.

If a someone wants to know which NB is associated with each NB number, the EU Commission operates the NANDO information system as a database, allowing you to search each of the 60+ NBs by CE marking 4 digit number. The database also allows searching by: country, annex/article, product and horizontal technical competence.

If your company is selecting a NB, you can search the product and technical competency categories to identify which NBs are able to issue CE certificates for your product. There are ten possible technical competencies to use as search criteria. For example, if your company manufactures absorbable sutures (i.e., competency, MDS 7009) there are only 32 NBs (shrinking every day) that have the technical competence to assess your Design Dossier for conformity with the MDD.

If your company is developing porcine-based collagen implants (i.e., competency, MDS 7010), then there are only 24 NBs (shrinking every day) able to issue a Design Examination Certificate for CE Marking. If your company needs additional guidance on how to select a NB, you might consider reading a blog on certification body selection.

Posted in: CE Marking

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