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Know Your EU MDR/IVDR Deadlines? Clarifications Contain A Few Surprises

 
• By Amanda Maxwell

Having trouble understanding the deadlines for complying with the EU's new MDR and IVDR? Two new documents aim to shed light on the chaos. But will they be clear enough?

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The implementation timing of the EU's new Medical Device and IVD Regulations is multi-layered. The texts anticipate the risk of not having sufficient time to set up all the needed structures, and, as a result, they feature some complex transitional arrangements. Many in industry, however, have criticized the approach for being too difficult to understand.

The Transition Sub Group (TSG) of the Competent Authorities for Medical Devices group (CAMD) is now trying to come to...

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