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Legacy Devices In Eudamed Database: MDCG Proposes Regulatory Solution

 
• By Amanda Maxwell

The new EU medical device regulations  ̶  the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.

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With just over a year to go until the full application of the new EU Medical Device and IVD Regulations, the European Commission’s Medical Device Coordination Group (MDCG) has published its interpretation of the legal gap in the Regulations concerning the registration of legacy devices in the Eudamed database.

Interpretation was necessary as there is a lack of “any explicit reference” to Unique Device Identification (UDI) obligations” for legacy...

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