MDCG 2019-11 — Qualification and Classification Analysis#

Step 1: Is MADDENING a Medical Device?#

No. MADDENING is a general-purpose computational framework.

Per MDCG 2019-11 Section 3.2, software that is a “general purpose computing platform” or “general purpose scientific tool” is not a medical device. MADDENING falls squarely in this category:

  • It computes physics simulations (heat diffusion, fluid dynamics, rigid body mechanics)

  • It provides infrastructure (graph management, coupling, differentiation, surrogates)

  • It does not process patient data

  • It does not make clinical predictions

  • It does not have a medical intended purpose

  • It has no specific clinical claim

MADDENING is comparable to MATLAB, NumPy, FEniCS, or OpenFOAM — tools that can be used in medical device software but are not themselves medical devices.

EU MDR Article 2(1) analysis: A medical device must have a “specific medical purpose.” MADDENING has no medical purpose — it is a physics simulation framework. The fact that downstream tools may use MADDENING for clinically relevant simulation does not make MADDENING itself a medical device, just as MATLAB is not a medical device because it is used in medical device development.

Step 2: How Would a Downstream Product Be Classified?#

When a downstream commercial entity builds a regulated product on MADDENING:

Intended Use Mode

Rule 11 Analysis

EU MDR Class

IMDRF Category

Research / pre-clinical simulation

Not a medical device (no clinical intended purpose)

N/A

N/A

Intraoperative digital twin (surgical decision support)

Rule 11(b): “intended to provide information which is used to take decisions with diagnosis or therapeutic purposes” + potential for irreversible neurological harm

Class IIb minimum, likely Class III

III–IV

RL policy generation for microrobot control

Rule 11(c): “intended to monitor physiological processes” in active control loop for CNS device

Class III

IV

IMDRF SaMD Risk Framework Alignment#

IMDRF Factor

Assessment

Significance of information

Treat/Diagnose (for intraoperative use)

State of healthcare situation

Critical (CNS, irreversible harm possible)

→ IMDRF Category

IV (highest risk)

This IMDRF Category IV maps to EU MDR Class III per MDCG 2019-11 Table 3.