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See today's BioWorld MedTech
Home » European Commission proposes additional year for IVDR implementation
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European Commission proposes additional year for IVDR implementation

Oct. 14, 2021
By Mark McCarty
The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.
BioWorld MedTech Regulatory Diagnostics Europe

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