Qualification and Classification of Medical Devices and IVDs in France (ANSM Reference)

Qualification of Medical Devices and IVDs

Qualification determines whether a product falls within the scope of medical device (DM) or in vitro diagnostic medical device (DMDIV) regulations. According to Article 2 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), a product qualifies as a medical device or IVD if it meets the specific intended purpose definitions and is not covered by other sectoral legislation (e.g., medicinal products, cosmetics, biocides).

Key Qualification Criteria

• Intended purpose declared by the manufacturer is decisive (not actual use by others).
• Borderline products require case-by-case assessment using European Commission guidance (e.g., MEDDEV 2.1/3 rev.3 for borderline products, MDCG documents).
• Software qualifies as a device when it has a medical purpose (diagnosis, prevention, monitoring, treatment, alleviation) independently or as accessory.
• Products without medical purpose but with similar risk profile (e.g., certain aesthetic devices) may fall under MDR Annex XVI.

Specific Cases

• Software and AI: Standalone software is a device if it processes data for medical decisions. AI/ML-based systems follow the same qualification but require special attention to intended purpose specificity and change management.
• Combination products: Drug-device combinations follow MDR rules if the principal mode of action is device; otherwise, medicinal product rules apply.
• Accessories: Qualify as devices if specifically intended by the manufacturer to enable or assist a device.

Classification Rules

Classification assigns risk classes (I, IIa, IIb, III for DM; A, B, C, D for DMDIV) determining conformity assessment procedures.

Medical Devices (MDR)

• Rules 1–8 of Annex VIII cover non-invasive, invasive, active devices, and special rules (e.g., Rule 11 for software).
• Software is classified independently unless driving/controlling a hardware device.
• Rule 11 (software): Class IIa minimum unless providing information used for diagnosis/treatment decisions (then IIb or III if decisions have impact on health/safety).

In Vitro Diagnostic Devices (IVDR)

• Rules A–F of Annex VIII classify based on intended use (e.g., Rule D for high public health risk IVDs like HIV screening → Class D).
• Self-tests and near-patient tests often higher class.

Practical Application

• Use MDCG 2019-11 guidance for software qualification and classification.
• Classification must consider intended purpose, manufacturer claims, and worst-case reasonably foreseeable use.
• Reclassification possible after MDR/IVDR transition periods or significant changes.

Borderline and Combination Products

• Borderline manual (latest version) and MDCG documents assist in qualification.
• For drug-device combinations: Article 1(4) MDR and Article 1(2) IVDR define boundaries.
• Consultation with competent authorities (e.g., ANSM for France) recommended for ambiguous cases.

Practical Advice for Manufacturers

• Document intended purpose precisely from development stage.
• Consult relevant MDCG documents, IMDRF guidance, and ANSM resources early.
• For software/AI: Clearly define output use in clinical pathway and justify classification.
• Seek ANSM opinion for borderline/complex cases via pre-submission meetings.

This framework ensures consistent application of EU MDR/IVDR in France while providing tools for manufacturers to navigate qualification and classification. Réglementation relative aux dispositifs médicaux (DM) et aux dispositifs médicaux de diagnostic in vitro (DMDIV) - ANSM