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Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

21 Dec 2021

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

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The Council of the EU’s 20 December adoption of the European Commission’s proposal to extend the transition deadlines for certain IVDs under the forthcoming IVD Regulation has been welcomed by industry as a victory for common sense. It is a recognition of the need for a workable transition into the new EU IVD regulatory framework, said Medtech Europe.

The European Parliament adopted the proposal last week. (Also see "IVDR Amending Proposal And New Transition Provisions Due To...