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.

 

2 thoughts on “Step 1: Decide the intended use and classification”

  1. How should we apply the new EU MDR directive for a medical device class 1 non measuring non sterile product that has already been on the market for tens of years.

    Are there any guidelines for a product that is not under development but already on the market?

    1. Thank you for your question about MDD Class 1 self-certified devices.

      Medical devices that were Class I self-certified under the MDD and do not depend on the availability of MDR-designated Notified Bodies in order to comply with the MDR. These devices must comply with the EU MDR by the date of application, i.e., 26 May 2020.

      For clarification: The legal concept of placing on the market refers to each individual product, not a type of product or model. It means your product has not, as you wrote, “already been on the market for ten years”, because each individual product can only be placed on the market (offered for sale/supply) after it has been manufactured. Please refer to the European Commission “The ‘Blue Guide’ on the implementation of EU products rules 2016”.

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