What rules should be applied to 3D printed - patient specific products?

The biggest question here is what is the intended purpose of the device. Depending on the purpose of the product, and thus the classification of the product, it depends on whether it is necessary to put the CE mark on the product and what documentation needs to be prepared.

Only implantable and Class III custom-made products require the affixing of the CE mark and the inclusion of a Notify body in the whole process. For all other classes, it is sufficient to prepare technical documentation for the product as described in Annex 13.

For more information, see:

• EU MDR Annex 13 - Procedure for custom made devices - https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/