With the imminent final adoption of the EU’s AI Act, EU industry association, MedTech Europe, has published a series of recommendations to ensure “a clear and practical applicability” of the new ruling to the medical technology sector.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.
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Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.