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The Commission and the Council on the MDR state of affairs

The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see…

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Article

Corrigendum 2 and the (potential) consequences for class I devices

Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains…

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Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go…

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