July 9, 2021

EU MDR CE Marking On Advertising Materials

Though many of us have undoubtedly observed the placement of a CE mark on promotional flyers, I suggest that such a practice is contrary to the basic product-inscription intentions established by the European authorities for use of the CE mark.  Accordingly, I recommend against placing CE marks on advertising literature, websites, and other promotional pieces, except for “sales packaging” (i.e., artwork on physical boxes, pouches, etc.).  I explain further below.

When reviewing the basic principles for CE marking in EU MDR Article 20 and Annex V, in the Blue Guide, in Europe’s “common framework” for marketing of products, in Regulation (EC) 765/2008, and the like, the intrinsic focus is oriented toward the subject device’s physical, chemical, configurational, functional, etc., attributes, and the ability of those attributes to support the affixing of the CE mark inscription.  We know this to be true because key legislative concerns are visibility, indelibility, readability, dimensional, etc., with immediate provisions for alternative marking options regarding devices whose basic physical, chemical, configurational, functional “markability” (my own term) don’t permit the affixing of the CE mark to the device, where in such instances we can instead place the mark on the accompanying legislatively-driven documents (i.e., on the information supplied with device, i.e., on the EU MDR Annex 1 Section 23 information, i.e., on the label and instructions for use).

Another telling angle is the Blue Guide’s statement that “CE marking does not serve commercial purposes, i.e. it is not a marketing tool.”  Accordingly, I suggest that the EU MDR Article 20(5) reference to, “promotional material which mentions that a device fulfils the requirements for CE marking” [my emphasis added] should be interpreted as just that [i.e., as a “mention of”, i.e., as a promotion of, the device’s conformity), rather than to the actual affixing of a CE mark to the promotional materials.