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Visionairy Health Secures CE Marking for its AI-Based X-Ray Triage Tool
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Visionairy Health Secures CE Marking for its AI-Based X-Ray Triage Tool
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MDR ), which will
govern medical devices software (
MDSW )
in the EU, we turn to the transition periods certain MDSW can
benefit from before being required to fully comply with the
MDR.
Transitional periods are provided in Article 120 MDR. In part
due to the COVID-19 pandemic, the original text of Article 120 MDR
has been corrected by two corrigenda (I, II) and another Regulation to avoid additional burdens to
stakeholders and impasses in the supply of medical devices. The
changes introduced by these amendments are twofold: On the one
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MDR”), which will govern medical devices software (“
MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before being required to fully comply with the MDR.
Transitional periods are provided in Article 120 MDR. In part due to the COVID-19 pandemic, the original text of Article 120 MDR has been corrected by two corrigenda (I, II) and another Regulation to avoid additional burdens to stakeholders and impasses in the supply of medical devices. The changes introduced by these amendments are twofold: On the one hand, the scope of the existing transitional periods was substantially changed and now includes more devices. On the other hand, the MDR now reflects the pushed-back applicability dates of the MDR and their influence on the transitional periods.
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