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One Assessment, Two Regimes
Under Article 43(3) of the AI Act, a medical device that is high-risk under Article 6(1) is assessed within the existing MDR procedure, and the MDR class under Rule 11 decides whether it is high-risk at all. The relief is procedural: five requirement areas an MDR file does not fully cover still have to be added, change control has to satisfy two tests, and an existing notified body's power to assess the AI requirements is transitional. The first steps are a letter to the notified body, a portfolio map, a gap analysis of one file and one change envelope for both tests.
Key findings
- Article 43(3) puts the AI Act assessment of a device high-risk under Article 6(1) inside the MDR procedure: one technical file, one quality management system, one declaration of conformity.
- The MDR Rule 11 class decides: AI software at Class IIa or above is high-risk, while Class I software is outside Article 6(1), though not outside the Act.
- Existing medical devices notified bodies may assess the AI Act requirements under a transitional power, but must apply for designation under the AI Act by 28 January 2028.
In the paper
- One procedure, by Article 43(3)
- Rule 11 decides whether the device is high-risk
- One procedure does not guarantee one notified body
- The relief is procedural; the requirements are not
- Two change tests, one envelope
- The deferral is not spare time
- Where to start
Michael Clark
Chief Executive Officer, Standard Intelligence
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