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EU moves to fix failing medical and in vitro device rules and spur innovation

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A 'targeted' revision to the MDR and IVDR promises clearer timelines, proportionate oversight and faster access to innovative technologies.

The European Commission has unveiled its long-awaited targeted revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), aiming to ease the regulatory burden on manufacturers, while ensuring Europe’s high standards for patient safety.

The Commission estimates that the changes will result in cost savings of €3.3 billion per year, including €2.4 billion annual administrative savings.

“Our rules must provide clarity, predictability and flexibility to sustain Europe’s leadership and continue delivering for patients,” said Executive Vice-President...

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