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European Commission under pressure to further revise EU MDR and IVDR

European Commission under pressure to further revise EU MDR and IVDR

Someone in scrubs holding a medical device.

EU Health groups propose solutions to MDR and IVDR concerns

A mom soothes a child in bed while making a phone call.

Industry groups’ call for corrections to EU’s MDR prompts questions about the need for additional guidelines for products marketed to children

FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR

FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR