Does Your Health Software or Mobile Application Qualify as a Medical Device or IVD in France?

Regulatory Framework in France

In France, software or mobile applications intended for health-related purposes are assessed under EU Regulation 2017/745 (MDR) for medical devices or Regulation 2017/746 (IVDR) for in vitro diagnostic devices. The ANSM applies these regulations directly and provides practical guidance to help determine whether a software qualifies as a medical device (DM) or in vitro diagnostic medical device (DMDIV). Qualification depends primarily on the intended purpose set by the manufacturer, not on the technology or claims by third parties. Le logiciel ou l’application santé que je vais mettre sur le marché relève-t-il du statut de dispositif médical (DM) ou de dispositif médical de diagnostic in vitro (DM-DIV) ? - ANSM

Key Qualification Criteria

A software qualifies as a medical device if it is intended by the manufacturer to be used for one or more of the following medical purposes (MDR Article 2(1)):

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability.
• Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
• Providing information by means of in vitro examination of specimens derived from the human body (falls under IVDR if diagnostic).

If the software does not have a medical purpose, it is not a medical device (e.g., general wellness apps, fitness trackers without specific medical claims, administrative tools, or simple data storage).

Decision Trees and Practical Examples

The ANSM provides decision trees based on MDCG 2019-11 and other EU guidance to assist qualification:

Examples Qualifying as Medical Device (DM)

• Software that calculates insulin doses based on blood glucose input → DM (treatment).
• App providing diagnosis of skin cancer from photos → DM (diagnosis).
• Software monitoring vital signs to detect arrhythmias → DM (monitoring).
• AI-based tool predicting seizure risk from EEG data → DM (prediction).

Examples Qualifying as IVD (DMDIV)

• Software interpreting genetic test results for hereditary disease risk → DMDIV (in vitro examination).
• App analyzing images of blood smears for parasite detection → DMDIV.

Examples Not Qualifying as DM or DMDIV

• Wellness app tracking steps and calories for general fitness.
• Electronic health record system for administrative use.
• App reminding users to take medication (no medical decision-making).
• Simple data visualization of lab results without interpretation.

Software as a Medical Device (SaMD) Specifics

• Standalone software is classified independently.
• Software driving or influencing a hardware device is considered part of that device.
• Under MDR Rule 11, most SaMD falls into Class IIa or higher unless providing information used for decisions with impact on health (then Class IIb or III).
• AI/ML-based software requires special attention to intended purpose definition, validation, and change management.

Borderline and Low-Risk Cases

• Borderline products (e.g., apps with lifestyle advice) are assessed case-by-case using European Commission borderline guidance.
• Products without medical purpose but similar risk may fall under MDR Annex XVI (e.g., certain aesthetic or lifestyle software).

Practical Advice for Developers in France

• Define and document the intended purpose precisely from the start.
• Use ANSM and MDCG decision trees to self-assess.
• If uncertain, request ANSM opinion or use pre-submission meetings.
• For qualified devices, ensure compliance with MDR/IVDR requirements (classification, conformity assessment, UDI, EUDAMED registration).
• Monitor ANSM updates for France-specific interpretations.

Correct qualification early avoids regulatory delays and ensures patient safety. Le logiciel ou l’application santé que je vais mettre sur le marché relève-t-il du statut de dispositif médical (DM) ou de dispositif médical de diagnostic in vitro (DM-DIV) ? - ANSM