Consider and decide the “intended purpose” of your anticipated product. It is not for the user to decide the intended purpose but the manufacturer. Check whether the anticipated device fulfils the definition of a medical device in Article 2 (1). If it does, decide the classification in accordance with Article 51 and the rules contained in Annex VIII.

These initial decisions will influence many of the subsequent steps to be followed. It is therefore essential to take these decisions carefully and to be precise, especially if the product is likely to have a borderline medical purpose or could have a different classification depending on an interpretation of the rules.

Note: This definition also applies to devices offered to EU citizens via the internet (Article 6.), including diagnostic or therapeutic services.

Deliverables for demonstrating compliance:

(1) The rationale for deciding the product is a medical device,

(2) The statement of the intended purpose and users of the device,

(3) The device classification rational.


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