Impact of New EU Regulations on Software Classification as Medical Devices in France

Overview of the Regulatory Change

The replacement of the Medical Devices Directive 93/42/EEC (MDD) by Regulation (EU) 2017/745 (MDR) has introduced substantial changes to the classification of software intended to be used as medical devices. In France, the ANSM highlights that many software products previously classified as Class I under MDD (allowing self-certification) now fall into higher risk classes under MDR, particularly due to the new Rule 11 in Annex VIII. This shift increases regulatory requirements, including mandatory involvement of notified bodies for conformity assessment. Impact des nouveaux règlements européens sur la classification des logiciels - ANSM

Key Changes Introduced by MDR Rule 11

Under the previous MDD, software was classified based on the risk of the hardware it controlled or the intended purpose, often resulting in Class I status for standalone software. The MDR introduces a specific classification rule for software:

MDR Annex VIII Rule 11 – Software

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as:

• Class III if the decisions have an impact that may cause death or irreversible deterioration of a patient’s state of health.
• Class IIb if the decisions may cause serious deterioration or surgical intervention.
• Class IIa in other cases.

Software intended to monitor physiological processes (where the monitoring has an impact that may cause death or serious deterioration) is Class IIb; otherwise Class IIa.

This rule applies to standalone software (SaMD – Software as a Medical Device), leading to a general up-classification compared to MDD.

Practical Consequences for Software Manufacturers

• From Class I to Class IIa/IIb/III: Most standalone software previously self-certified under MDD now requires notified body assessment under MDR.
• Conformity Assessment: Higher classes necessitate involvement of a notified body for quality management system audit and technical documentation review.
• Transition Period: Legacy software (MDD certified) benefits from extended transitional provisions (e.g., validity until 2027/2028 depending on class), but new software or significant changes require full MDR compliance.
• Increased Requirements: Enhanced clinical evaluation, post-market surveillance, risk management, and UDI assignment.

Examples of Reclassification

• Software for radiotherapy planning that provides dose calculation information → Class IIb or III (therapeutic decision).
• App monitoring blood pressure to alert for hypertension management → Class IIa or IIb (monitoring with potential serious impact).
• Simple administrative software for patient scheduling → Not a medical device.
• Wellness app tracking general activity → Not a medical device unless specific medical claims are made.

Implications for French Manufacturers and Developers

• Early assessment of intended purpose is critical to anticipate classification.
• Manufacturers must update technical documentation, quality systems, and clinical evidence to meet MDR standards.
• Notified body capacity constraints may delay certifications; early engagement recommended.
• ANSM encourages use of MDCG 2019-11 guidance on qualification and classification of software and consultation for borderline cases.
• Non-compliance risks market withdrawal or restrictions.

The MDR’s stricter classification aims to enhance patient safety for software-based medical technologies but increases development and certification burdens. Impact des nouveaux règlements européens sur la classification des logiciels - ANSM