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Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices

This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more