MDD 93/42/EEC: A patient-specific implant (PSI) is a custom-made device. This means a device specifically made in accordance with a medical prescription which gives, under the doctor's responsibility, specific design characteristics and is intended for the sole use of a particular patient, of whom the name is mentioned on the prescription.
The MDD 93/42/EEC guideline explicitly mentions that PSIs may not bear a CE mark. Nevertheless the process of implant development complies with Quality Management System ISO-13485.
An oral prosthesis that is not implanted in the body, is not a PSI.