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Marie Gårdmark: ”The situation is not satisfactory”
”The legislative tool-box is limited, but carrots in the form of longer exclusivity has already proven successful, this has for example increased registration of new products in rare diseases. But will it also work to increase access for all EU patients
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Rapid developments in AI – “All stakeholders are struggling to understand it”
Artificial intelligence is being discussed more and more, and developments in the field are moving rapidly. As the Swedish Medical Products Agency testifies, keeping up with developments is not easy.
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"Unclear proposal from the EU Commission on how to solve the MDR challenges"
Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true.
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