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 an in vitro diagnostic medical device in Article 2 (2). If it does, decide the classification in accordance with Article 47 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 an IVD medical device,
(2) The statement of the intended use of the device,
(3) The device classification rational.
Guidance
Guidance is available from the Medical Device Coordination Group on borderline and classification questions:
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3.
- MDCG 2020-16 Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices
If, even as the manufacturer, you are unable to reach a decision on the classification of your future product, you can request a classification decision from your Competent Authority (of the Competent Authority of your authorised representative). The Competent Authorities have an agreed a procedure for handling such enquiries.
- Helsinki Procedure Helsinki Procedure for borderline and classification under MDR & IVDR
Guidance is also available from the Medical Device Coordination Group on the classification of software medical devices:
- Infographic Is your software a Medical Device?
- MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components.
- MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746.