Parliament and the Council have given their final approval: For AI in medical devices, the high-risk requirements will be postponed from August 2, 2027, to August 2, 2028.
For standalone high-risk AI, the obligations take effect on December 2, 2027; for AI used as a safety-critical component of a product under existing sector-specific legislation (e.g., MDR), they do not take effect until August 2, 2028.
However, the proposed exemption for MDR products will not be implemented. These products will be subject to both the rules of the AI Act and those of the MDR.
Here is the European Parliament’s report on the decision: AI Act: EP Approves Simplification Measures and “Nudifier” App Ban | News | European Parliament