MDR - Annex V
Original text
Expert opinion
CE Marking of Conformity
1. The CE marking shall consist of the initials ‘CE’ taking the following form:
Affix the CE mark on a product
The CE-mark stands for the term Conformité Européenne and must hold the form as given in Annex V of the Medical Device Regulation MDR 2017/745.
2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
A zoom-in or zoom-out is allowed to affix the CE mark on a product and thus, make it fit the available space on the product.
3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
For very small medical devices, the dimensions can be reduced below the indicated dimensions. However, a justification and waiver should be provided why the size is reduced to smaller dimensions than 5 mm.
Please note that not all medical devices allow to affix a CE mark, e.g. resorbably implants or similar products. In this cases, the affixing of the CE mark on the label is sufficient if justified.
