EU MDR delay for certain Class I devices moves forward: what it means for manufacturers

Makers of reusable Class I medical devices and Class I software are set to be upclassified under the European Union’s incoming Medical Device Regulation got an early holiday gift with the Council of the European Union’s second corrigendum. Under amendments proposed to EU MDR, they will get extra time to comply with the new rules, welcome news given the scramble to secure a notified body to review devices and complete conformity assessments by the May 26, 2020, deadline.

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