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Feedback to the European Commission on the Artificial Intelligence Act

Posted on 09.09.2021

On 6 August, MedTech Europe presented its response to the European Commission’s proposal for an Artificial Intelligence Act (AI Act), noting that it welcomes a robust and clear regulatory framework for Artificial Intelligence (AI), but pointing out some critical limitations of the AI Act that could lead to duplicated regulation and legal uncertainty. The main points raised by MedTech Europe were:

  • an overly broad definition of AI that could mean any type of medical device software could fall under the AI Act;
  • misalignment between the AI Act and the MDR/IVDR, including in the risk classification, definitions, and other provisions;
  • misalignment between the AI Act and the GDPR, where providers of medical technology may be unable to comply with the AI Act due to GDPR provisions.

In the coming months, as the AI Act will be scrutinised by the European Parliament and the EU Council, MedTech Europe will be sharing its views with policymakers with the objective that these challenges be addressed and to ensure that Europe can take full advantage of medical technologies powered with AI.  The proposal for an Artificial Intelligence Act (AI Act) was presented by the European Commission in April 2021, aiming to turn Europe into the global hub for trustworthy AI, by seeking to ban forms of AI considered harmful and submitting others to strict regulation according to the risk they present.