Commission proposal on extending IVDR transition and expediting EUDAMED adoption!

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Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the allotted time, the European Commission (EC) is once again suggesting an extension of the regulation’s transition period. Simultaneously, the Commission is proposing to hasten compliance with EUDAMED requirements, intending to gradually enforce the mandatory use of finalized modules.

Here is the Commission press release for detailed and additional information.