Software Asa Medical Device In Europe X2013 New Regulatory Regime About To Enter Into Force Part 6 Of News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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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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