The EU is moving forward with key upgrades to its medical device and diagnostics regulations, specifically under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Following years of regulatory bottlenecks, these changes are especially relevant to developers of diagnostics and Software as a Medical Device (SaMD).
At Axcellant, we help companies navigate this evolving landscape through trial design, submissions, and implementation. Greater predictability and clarity in the system open the door to faster innovation — a goal we fully support.
See how we guide medtech and diagnostics teams across the EU regulatory landscape.
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