MEDICAL DEVICES

IN VITRO DIAGNOSTIC MEDICAL DEVICES

Annex V: CE marking of conformity

1. The CE marking shall consist of the initials ‘CE’ taking the following form:

2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.

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.