Intended Purpose
The intended purpose, as defined in EU MDR Article 2(12), is the use for which a medical device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use, or in promotional or sales materials. It forms the basis for the classification of the product and is decisive for the evaluation of safety and performance. The intended purpose must be precisely formulated and must identify all intended clinical applications, target populations, and conditions of use.
The translation of the intended purpose demands the highest precision, as even minor deviations in wording can have regulatory consequences. The intended purpose must be semantically identical in every language version.
Frequently Asked Questions
Why is the correct translation of the intended purpose particularly critical?+
The intended purpose defines the regulatory framework of a medical device and determines its classification, required clinical evidence, and applicable general safety and performance requirements. An incorrect translation can result in the product being classified differently in a target market or even being considered non-compliant.