Intended purpose

The intended purpose drives classification, the clinical or performance evidence needed and the scope of the technical documentation. Promotional claims count, so marketing material can change the intended purpose without anyone meaning to.

‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;

EU MDR, Article 2(12)

‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;

IVDR, Article 2(12)

The MDR lists the label, IFU, promotional material and the clinical evaluation with 'and'. The IVDR uses 'or' before the last item and refers to the performance evaluation.