Speeding Up and Slowing Down: EU Proposes EUDAMED and IVDR Reforms

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The European Commission proposed this week to expedite mandatory reporting to the new EUDAMED database while extending out the transition times for legacy tests to comply with the IVD Regulation. The Commission also wants to add requirements for companies to disclose impending product shortages.

Device firms might have less time than projected to comply with mandatory registration in a new EU-wide medical device database. Meanwhile, diagnostics manufacturers could have more time to transition to the IVD Regulation.

Both of these changes would result from legal amendments to the EU Medical Device and IVD Regulation proposed by the European Commission January 23. The Commission also included requirements for manufacturers to notify authorities in advance of an anticipated supply disruption in the amendments, which must be approved by the European Parliament and Council before they are adopted. The reforms are the latest in a series of efforts by authorities to avoid product shortages while patching up MDR/IVDR implementation activities.

“Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow,” the Commission acknowledged in its announcement of the new proposals.


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