Defining the intended purpose of the future planned device is the starting point for all decisions, including whether the product is a medical device or not. Properly described, the intended purpose will provide; (a) confirmation, or not, of whether the product being considered fits the definition of a “medical device” and therefore whether or not the regulation applies. (b) the basis for the classification of the future planned device into one of the four classes of device, as required by Article 51. (c) core text which is needed for the future labelling, instructions, promotional or sales materials, the clinical evaluation and the technical documentation.

Intended purpose is defined in 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 and as specified by the manufacturer in the clinical evaluation;” In the product concept phase it is likely that the labels, instructions, promotional or sales materials don’t yet exist. Nevertheless, one should start defining the intended purpose by considering how the product will be promoted, to who and with what messaging. It is important to recognise the intended purpose is not a description of product features and specifications but a description of the intended medical use.

The Intended purpose is best composed by a medical professional, ideally someone with experience of medical writing. It should be written for the intended user group, medical professional or patient, using appropriate medical language.

The intended purpose is usually a short statement of two or three sentences that focuses on what the device is intended to be used for.  It is a required item in the Technical Documentation (Annex II, 1.1)

(a) general description of the device including its intended purpose and intended users;

However, it is advisable not to develop the intended purpose statement in isolation but together with the two other statements in the Technical Documentation with which the intended purpose needs to be consistent:

(c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;

(d) principles of operation of the device and its mode of action, scientifically demonstrated if necessary;

Written together, these three statements (a), (c) and (d) should provide the basis for developing two additional statements required by Annex II, 1.1;

(e) the rationale for the qualification of the product as a device;

(f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;