The classic trap
Many medical device and IVD manufacturers confuse two distinct classification regimes: the AI Act's and that of Regulations MDR (EU 2017/745) and IVDR (EU 2017/746). Recital 51 clarifies that an AI system classified as high-risk under the AI Act does not automatically become a class IIa, IIb or III device under MDR/IVDR, and vice versa. The EU AI Office and MDR notified bodies will each apply their own grid, requiring a dual conformity mapping or the product will be refused CE marking.
Practical pitfalls of dual classification
- A class IIa diagnostic support software under MDR may qualify as high-risk under the AI Act (Annex III) and trigger two separate third-party conformity assessments.
- Conversely, a high-risk AI system (e.g. HR screening) is not a medical device and falls outside MDR/IVDR scope.
- The third-party conformity assessment required by MDR/IVDR for medium and high-risk products must integrate AI Act requirements (risk management article 9, data quality article 10, technical documentation annex IV) without duplicating them.
- The EU declaration of conformity must reference both the AI Act and the applicable sectoral regulation simultaneously.
- MDR/IVDR notified bodies must now also be designated for the AI Act, creating a real bottleneck on the market.
The articulation test: an integrated conformity procedure
The operational stake of recital 51 is to avoid double documentary burden while respecting each regime. The AI Act explicitly provides (article 8) that the AI technical documentation may be integrated into the existing MDR/IVDR documentation, provided that all requirements are covered. This integration cannot be improvised: it requires a precise correspondence matrix between AI Act annexes and those of the sectoral regulation.
How Luxgap automates this risk
Our Luxgap Dual-Regime Mapper eliminates the grey zone between the AI Act and sectoral regulations (MDR, IVDR, machinery regulation, toys, lifts) by producing a unified mapping of your obligations. The tool ingests your existing technical documentation (PDF, Word, eQMS structures such as Greenlight Guru, Matrix Requirements, Polarion) and automatically identifies AI Act requirements already covered, those partially covered and those to be completed, without asking your Quality Manager to fill in a single spreadsheet.
- Automatically detects the applicable regime for your product (AI Act only, MDR + AI Act, IVDR + AI Act, machinery regulation + AI Act) based on functional description and intended purpose.
- Generates a correspondence matrix between MDR/IVDR essential requirements (annex I) and AI Act requirements (articles 9 to 15), flagging eliminable documentary duplicates.
- Classifies your system under both grids in parallel: MDR class (I, IIa, IIb, III) and AI Act level (high-risk, limited risk, minimal) with defensible justification.
- Identifies notified bodies designated for both the AI Act and your sectoral regulation, and alerts if your current notified body covers only one regime.
- Produces an integrated EU declaration of conformity referencing both regulations simultaneously, ready to sign.
- Generates a timestamped PDF report admissible during an audit by your notified body or by the EU AI Office.
Available as a complement to a Luxgap DPO or CISO mandate or as a dedicated SaaS module depending on your scope. Request a personalised quote and our teams will prepare a demonstration on your actual technical file, with a free white audit within 48h to measure your exposure before any engagement.
